Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Voluntary recall of implantable cardiac defibrillators by guidant corporationjune 18, 2005
the department of health today (june 18) noted a worldwide recall of certain implantable cardiac defibrillators issued by the guidant corporation today. the affected devices are –
ventak prizm 2 dr (model 1861) icds manufactured on or before april 16, 2002
contak renewal (model h135) and contak renewal 2 (model h155) crt-ds manufactured on or before august 26, 2004
ventak prizm avt, vitality avt, renewal 3 avt and renewal 4 avt icds (all series numbers)
individual patients implanted with affected devices should contact their attending doctors and keep regular appointment. in case they feel an electrical shock, or hear an audible “beeping” from the device, they should immediately contact their doctor or go to the nearest hospital emergency department.
the department of health has informed public and private hospitals, medical professional associations and relevant patients’ groups about this recall action today.
guidant corporation has posted information for physicians on its web site at www.Guidant.Com.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Corrective action of guidant implantable cardiac pacemakers
19 july 2005
the department of health has been notified by the guidant corporation of an “urgent medical device safety information and corrective action” concerning some of their implanted cardiac pacemakers.
the pacemakers in question may experience premature battery depletion without warning, inappropriate pacing and early display of replacement indicators.
the affected pacemakers are pulsar max, pulsar, discovery, meridian , pulsar max ii, discovery ii, virtus plus ii, intelis ii and contak tr pacemakers manufactured between 25 november, 1997 and 26 october, 2000.
if these devices exhibit the above failure mode, patients may notice prolonged rapid heart beating and develop dizziness. in serious circumstances, though uncommon, they may develop heart failure symptoms such as shortness of breath and loss of consciousness.
the manufacturer has sent letters to doctors with patients implanted with the pacemakers to alert them of the incident, and advise replacement of the pacemakers where necessary.
affected patients are urged to contact their doctors for advice.
guidant hong kong limited has set up two hot lines 2593 2210 and 6292 2308 for public enquiry during office hours.
the department of health has alerted the hospital authority, private hospitals and medical associations of the corrective action undertaken by guidant on some of their cardiac pacemakers.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety information regarding guidant insignia and nexus implantable cardiac pacemakers
september 23, 2005
the department of health has been notified by the guidant corporation
of an "important medical device safety information and corrective
action" concerning their insignia and nexus implantable cardiac
pacemakers.
the concerned pacemakers may not function properly without warning
and can result in serious health complications, such as syncope
which required emergency hospitalization. there have been no reported
deaths associated with the malfunction of the affected pacemakers.
the manufacturer has advised doctors in hospital authority and
private hospitals of this important safety information. there are
115 patients implanted with the affected devices in hong kong and
they will be informed by their doctors for follow up actions in
a few days' time.
the department of health has alerted the hospital authority, private
hospitals and medical associations of this safety information.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety information regarding st. jude medical implantable cardioverter defibrillators
10 october 2005
the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly.
according to st. jude medical (hong kong) ltd., the affected models are:
photon dr (model v-230hv) (certain serial numbers)
photon micro vr/dr (models v-194/v-232)
atlas vr/dr (models v-199/v-240)
no serious patient injury or death has been reported so far.
there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Voluntary recall of two models of omron® 3-way instant
thermometers by omron healthcare, inc.
3 november 2005
the department of health (dh) noted a voluntary recall of two models
of battery-operated digital thermometers produced by omron healthcare,
inc. today (3 november).
dh advised the public to stop using the models concerned. no complaint
or report of serious injury has been received by dh or the company
so far.
the recall was initiated by the company following reports of the
potential problem of overheating of the tip of the device, resulting
in users' discomfort and possibly redness or blister.
very young children using these products are at a higher risk because
of their inability to express themselves clearly and the difficulty
in pulling away the device held by an adult.
the affected products are omronr 3-way instant thermometers, with
model numbers mc-600 and mc-600can and lot numbers beginning with
01-32, 01-36, 01-37 and 01-38. the lot numbers can be found inside
the battery compartments of the thermometers.
members of the public can call the telephone hotline of the company
at 2796 2907 during office hours (monday to friday 9 am - 5:30pm
and saturday 9 am - 1 pm) for enquiries.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Follow-up action on medtronic sigma® pacemakers
1 december 2005
the department of health was informed by medtronic international ltd. today (december 1) that the company was following up on some medtronic sigma pacemakers.
according to the company, the concerned pacemakers may fail due to separation of interconnect wires and may cause loss of rate response, premature battery depletion, intermittent or total loss of signals.
models affected included sd203, sd303, sdr203, sdr303, sdr306, svdd303, ss103, ss106, ss203, ss303, ssr203, ssr303, ssr306, svvi103.
patients are recommended to consult their doctors immediately if they experience dizziness or loss of consciousness. there is no reported patient injury or death associated with this failure so far.
the hospital authority and private hospitals have been informed of this follow up action. there are totally 103 patients implanted with the affected devices in hong kong and they will be informed by the hospitals for follow up actions in a few days' time.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Removal of contraceptive device
13 december 2005 (tuesday)
the department of health (dh) has received five reports of breakage and expulsion of a batch of intra-uterine contraceptive device (iucd) in the past 12 months and women using such devices will be contacted for follow-up.
as the contraceptive effect may be affected, dh and the family planning association of hong kong (fpahk) will contact the concerned women for checkups including the removal and replacement of iucd if necessary.
a total of 1161 pieces of the iucd, of model copper t 380a and batch number fd 010201, had been used by dh's family health services and fpahk between 2001 and 2003.
the supplier of the affected device was medico techno pte ltd. of singapore .
a dh spokesman said the replacement is a precautionary measure as there has not been any report of major side effect related to using the affected iucd so far.
"in the past 12 months, fpahk has reported a total of 5 cases of the device found broken and being partially or completely expelled from the uterus. no similar occurrence has been noted in dh's clients.
"broken and expelled iucd will obviously affect contraceptive effect. women inserted with iucd should immediately consult their doctors and take other contraceptive measures if the iucds are found expelled."
"using iucd is a very effective and safe method of contraception. it carries uncommon complications such as expulsion and pelvic infection. women inserted with iucd should immediately consult their doctors if they suspect to be pregnant, or have abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge ," he added.
the spokesman reminded women inserted with all models of iucd to attend checkups regularly.
dh and fpahk are taking steps to contact their clients for follow-up.
dh has set up telephone hotlines 2961 8839 and 2961 8740 to answer public enquiries on the matter. the hotlines will operate until 9 pm today and during office hours from tomorrow. the hotline of fpahk is 2919 7725.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Removal of contraceptive device
24 december 2005 (tuesday)
the department of health (dh) had contacted all the 261 women using a same batch of copper t380a intra-uterine contraceptive device (iucd) which reported to have five incidents of breakage and expulsion in the past 12 months.
a dh spokesman said: "out of the 261 clients contacted, 51 of them have the iucds removed at dh's maternity and child care centre. all the iucd were found intact."
"dh's follow-ups also revealed no report of pregnancy arising from the breakage of iucd had been received."
dh's hotline had received a total of 204 enquiries.
the family planning association of hong kong's (fpahk) have sent out letters to all their clients and so far none reported being pregnant. a total of 59 clients have their iucds removed by fpahk. two of these iucds were found to be broken on removal.
a total of 1161 pieces of the same batch of the affected iucds were used by dh's family health services and the family planning association of hong kong (fpahk) between 2001 and 2003.
in view of the rising incidence of breakage reports, dh decided to remove the iucds from the clients as a precautionary measure.
the spokesman stressed that using iucd is a very effective and safe method of contraception. it carries uncommon complications such as expulsion and pelvic infection. women inserted with iucd should immediately consult their doctors if they suspect to be pregnant, or have abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge .
the spokesman reminded women inserted with all models of iucd to attend checkups regularly.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Dh notified of intra-uterine contraceptive device cases
18 january 2006 (wednesday)
in response to media enquiries, a spokesman for the department of health confirmed that the department has received notification from family planning association of hong kong (fpahk) that it was calling back all clients inserted with copper t 380a intra-uterine contraceptive device (iucd) for removal with or without replacement with another type of iucd.
the association observed two cases of partially broken copper t 380a iucd of batch number 60401 and decided to call back all patients concerned as precautionary measure because broken iucd could lead to reduced contraceptive efficacy.
the spokesman said that dh has alerted hospital authority, private hospitals, professional associations and medical practitioners of the incident of breakage of the batch of iucds .
so far, no serious injuries related to breakage of these iucds have been reported locally or overseas.
the spokesman said that dh did not use copper t 380a iucd of this batch. he called on women with iucds inserted should consult their doctors for advice.
“if they suspect that they are pregnant or have symptoms of abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge, they should consult their doctors immediately,” he said.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Public reminded to clean contact lens properly
the centre for health protection (chp) of the department of health today (february 18) called on members of the public to properly clean and disinfect contact lens to prevent keratitis – inflammation of the cornea of the eye.
the appeal was made following seven cases of fungal corneal infections were reported in singapore earlier this year. all of them are users of contact lens. information obtained from the singapore ministry of health indicated that of the 19 affected persons identified since may 2005, 18 used bausch and lomb's (b&l) renu multipurpose contact lens solution, a chp spokesman said. as for hong kong, the spokesman said the number of fungal kertitis cases admitted to public hospitals has remained stable in the past six months, recording a monthly average of two to three cases. "chp investigations last year revealed that some local fungal keratitis patients had also recalled using the b&l contact lens solution. "chp has earlier requested b&l manufacturer to examine its product and the company determined that the incident was not attributable to the product. sterility tests performed by the chp for samples of the products bought from local market were also negative for fungal infections," the spokesman said. in response to the recent increase in the number of cases in singapore, the chp has contacted the b&l manufacturer to obtain more update information and investigate further about possible relationship between their product and fungal keratitis cases. the chp will send letters to doctors alerting them about the situation and to be on the lookout for fungal keratitis infections. more b&l contact lens solutions will be tested for fungus and other microbes. the spokesman reminded users of soft contact lens to observe the following in the prevention of contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
do not wet your lens with saliva, bottled water or tap water;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists;
discard contact lens disinfections after one month of opening;
do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
regular check up by your optometrists/ophthalmologists;
remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and
consult eye doctors if symptoms of keratitis developed such as eye pain, redness etc.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Dh keeps close watch on fungal corneal infections in singapore
the department of health (dh) supports the decision of bausch & lomb (hong kong) ltd (b&l) to voluntarily suspend sales of its renu multipurpose solution in hong kong.
a dh spokesman today (february 22) said the arrangement is a prudent and precautionary measure in view of the detection of cases of fungal corneal infections (keratitis) involving users of the solution in singapore and hong kong. dh expressed concern over the development in the country and held a teleconference with singapore ministry of health yesterday (february 21) to exchange information on fungal infections of the two places. the department also met with representatives of b&l, microbiological experts, ophthalmologist, optometrists and consumer council on the same day to discuss the situation in hong kong. the department advised b&l to look into the problem and take necessary measures to protect local consumer. updated information from singapore showed that there have been 39 cases since 2005 with a spike of cases in january 2006. thirty-four of these 39 cases said that they had used a renu multipurpose solution by b&l. in hong kong, the average number of fungal keratitis cases between june 2005 and january this year based on the hospital authority's in-patient discharge records was two to three per month. "of the 16 cases interviewed by dh during this period, 12 reported having used the product on repeated interviews. dh is conducting sterility tests on the product, and preliminary results are expected later this week." "dh and its singapore counterparts are jointly investigating the cause for this phenomenon," the spokesman said. dh also approached international authorities to inquire if cases of fungal keratitis involving contact lens users were also reported in other countries, he added. "we will continue to maintain close liaison with b&l to monitor the development and will provide updated information to the public," the spokesman said. he pointed out that a letter to doctor has been issued earlier alerting them to fungal keratitis and asking them to refer such cases to ophthalmologists. "dh has solicited support from optometrists and ophthalmologists to enhance public education on the proper use of contact lens and contact lens solutions," the spokesman said. contact lens users are advised to consult optometrists/ophthalmologists for professional advice, and to observe the following measures:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
do not wet your lens with saliva, bottled water or tap water;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists;
discard contact lens disinfections after one month of opening;
do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
regular check up by your optometrists/ophthalmologists;
remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and
consult ophthalmologists if symptoms of keratitis developed such as eye pain, redness etc.
dh has set up a hotline (2125 2727) to answer public enquiries. it will be operated up to 9 pm today and during office hours from tomorrow onwards.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has traced and recorded 23 cases of fungal corneal infection (keratitis) among local contact lens users following reports of this kind were found in singapore and hong kong recently.
a chp spokesman said these cases comprised six males and 17 females aged between 16 and 51. twenty of them sought medical consultations from public hospitals and three others received medical treatments in private hospitals between may 2005 and february this year. "dh has contacted 22 of these patients. twenty-one claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the spokesman said preliminary results of sterility tests on 20 samples of b&l renu contact lens solutions by dh are negative. "we are maintaining close communication with other agencies for further findings and developments," he said. meanwhile, dh!|s hotline has so far received more than 2 000 enquiries from members of the public. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
do not wet your lens with saliva, bottled water or tap water;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists;
discard contact lens disinfections after one month of opening;
do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
regular check up by your optometrists/ophthalmologists;
remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and
consult eye doctors if symptoms of keratitis developed such as eye pain, redness etc.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received four more reports of fungal corneal infection (keratitis) since early march, bringing the total number of contact lens users affected to 27 since the infection was firstly reported in may 2005.
a chp spokesman said the four recent cases comprised three males and one female aged between 17 and 43. "of the 27 patients, 26 were interviewed and 25 of them claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year as a prudent measure to protect consumers. "we are also maintaining close communication with the health authorities of singapore and the united states where cases of this kind were also reported in order to obtain the latest information and findings from them," he said. in the united states, 109 cases with suspected fungal keratitis were under investigation. of the 30 patients for whom complete data were available, 28 were soft contact lens users. twenty-six of them reported using b&l contact lens solution. in singapore, out of the 75 affected persons, 59 were sure of the contact lens solution used. of these, 56 said they had used b&l renu multipurpose contact lens solution. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories;
attend regular check up by optometrists/ophthalmologist and follow their instructions of cleaning and disinfection procedures for contact lenses and the accessories;
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists;
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time;
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily;
all contact lens solution should be capped properly after use;
discard contact lens solutions after one month of opening;
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination;
all contact lenses, solutions and accessories should be stored in a cool and dry place;
disinfect the case weekly by soaking in just-boiled water for 10 minutes;
replace case every three months;
disposable contact lens must not be used beyond their recommended disposal period;
do not wet your lens with saliva, bottled water or tap water;
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists/ophthalmologists. seek medical advice promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Update on advice for prevention of fungal corneal infections
the centre for health protection (chp) of the department of health today (april 24) provides updates on cases of fungal corneal infections and advice on prevention.
in hong kong a total of 27 cases were reported to the chp since the infection was firstly reported in may 2005. of the 27 patients, 26 were interviewed and 25 of them claimed that they were users of bausch and lomb (b&l) renu multipurpose contact lens solution. the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year as a prudent measure to protect consumers. in a recent development, the us food and drug administration (fda) updated its recommendation and advise contact lens wearers to stop using b&l renu with moistureloc products, discard all remaining solution including partially used or opened bottles. the department of health echoes fda's updated recommendation and reiterates that further investigations are needed to identify the cause of the problem. "we are maintaining close communication with the health authorities in us and singapore to help determine the contributing factors and products that place contact lens users at risk for the infection," the spokesman said. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received five more reports of fungal corneal infection (keratitis) since mid-april, bringing the total number of contact lens users affected to 32 since the infection was firstly reported in may 2005.
a chp spokesman said the five recently identified cases comprised two males and three female aged between 21 and 28 who had attended public hospitals last year.
“of the 32 patients, 31 were interviewed and 29 of them claimed that they were users of b&l renu multipurpose contact lens solution.”
the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year.
“chp will continue to monitor the local situation closely,” the spokesman said.
he reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Update on cases of fungal corneal infections
the centre for health protection (chp) of the department of health (dh) has received one more report of fungal corneal infection (keratitis) this month, bringing the total number of contact lens users affected to 33 since the infection was firstly reported in may 2005.
a chp spokesman said the newly identified case was a 40-year-old man who attended a public hospital in april this year.
“of the 33 patients, 32 were interviewed and 29 of them claimed that they used only b&l renu multipurpose contact lens solution,” he said.
preliminary results of case-control study conducted by the chp in connection with fungal keratitis found a significant association between development of fungual keratitis and the use of renu solution among disposable contact lens users in hong kong. the association is present even after adjusting for hygiene and other factors.
“the finding is consistent with that from a case-control study conducted in singapore,” the spokesman said.
noting that the manufacturer announced a worldwide recall of the renu with moistureloc multi-purpose contact lens solution yesterday, the spokesman said dh supported the recall and called on contact lens users to stop using the product including partially used and opened bottles.
the chp will also continue to monitor the local situation closely.
he reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Voluntary recall of heartbeat regulating products
27 june 2006 (tuesday)
the department of health (dh) received notification from a medical device manufacturing company about a voluntary recall of a number of devices used for regulating heartbeats, including cardiac pacemakers, cardiac resynchronization therapy pacemakers (crt-ps), and cardioverter defibrillators (icds).
the notification from guidant hong kong limited involved the following products -
insignia pacemakers,
nexus pacemakers,
contak renewal tr crt-ps,
contak renewal tr 2 crt-ps,
ventak prizm 2, icds,
vitality icds, and
vitality 2 icds.
it was found that five devices did not function as a result of failure of the capacitor leading to intermittent or permanent loss of output or premature battery depletion. to date, about 49 800 devices have been distributed and approximately 27 200 devices have been implanted worldwide.
there have been two overseas reports of pacemaker patients experiencing syncope. there have been no other reported serious incidents locally, no reports of adverse incidents have been received by dh.
according to guidant hong kong limited, i n hong kong , 32 devices have been implanted in hospitals under hospital authority (ha) and private hospitals. guidant has contacted ha and related doctors to advise them to follow up patients in their clinics as soon as possible.
individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call guidant hong kong limited's hotline at 2593 2206 for enquiry.
the dh has informed public and private hospitals, and medical professional associations about this recall action and advise them to take necessary follow up actions. dh welcomes the timely actions taken by guidant as a responsible manufacturer to issue this recall.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Software problem found in programming devices for implantable pacemakers
the department of health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers.
the programming devices concerned, produced by st. jude medical inc., are aps iii model 3500/3510 programming devices (software versions 6.1.1 and earlier) and merlin pcs model 3650 programming devices (software versions 4.1.1 and earlier). they are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company -
identity sr model 5172
identity dr model 5370
identity xl dr model 5376
a spokesman for dh said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. the details can be found at the corporate website of st. jude medical, inc. at www.Sjm.Com .
dh has alerted the hospital authority, private hospitals and other relevant medical professional organisations of this safety information.
no patient injury or death has been reported so far.
the spokesman said patients shall call the hotlines of st. jude medical ( hong kong ) ltd at 2996 7688 from 9 am to 6 pm from monday to friday for enquiries. they can call 9666 4545 or 9777 0097 outside office hours.
he reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. if they have any symptoms of heart disease, they should seek medical attention immediately.
end/thursday, october 19, 2006
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Dh monitoring recall of four amo contact lens solution the department of health is monitoring the voluntary recall of specific lots of four types of contact lens solutions by its manufacturer from the local market due to a concern about their sterility.
the concerned contact lens solutions, manufactured by advanced medical optics, inc. are:
lens plus ocupure saline 360 ml (lot no.: zb02767, zb03156, zb03174, zb03191)
complete protec formula multi-purpose solution 350ml (lot no.: zb03266)
complete moistureplus multi-purpose solution 60ml sample pack (lot no. zb03194)
complete moistureplus multi-purpose solution 60ml sample pack (lot no. zb03194)
a dh spokesman said that the company has notified the department that these lots are being recalled because of production-line problems at its manufacturing plant in mainland, which could affect the sterility of the product.
the spokesman said, "so far, dh has not received any report of related injury."
he said, "users should stop using the affected lots and should consult their doctors in case of discomfort or infection. they may call the company’s hotlines at 2401 5811/2 in case of queries."
the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
ends/wednesday, november 22, 2006
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Dh and customs keep close watch on recall of contact lens solutions the following is issued jointly by department of health and customs and excise department:
representatives of the department of health (dh) and the customs and excise department met today (november 23) to discuss the latest situation regarding the voluntary recall of ten lots of four types of contact lens solutions manufactured by advanced medical optics, inc.
a telephone hotline 2125 1133 has been set up by dh to provide health advice to the public. contact lens users using the concerned solutions with symptoms of infection or discomfort are also urged to call the hotline. it will be operated during office hours.
according to the information provided by the manufacturer, testing of the concerned solutions produced at its manufacturing plant in the mainland indicated microbial contamination.
a dh spokesman said: “the centre for health protection (chp) is liaising with local ophthalmologists, optometrists and hospital authority for finding suspicious cases for necessary investigations.”
the customs and excise department is monitoring the recall process of affected lots of concerned contact lens solutions and will enhance surveillance by taking samples of the solutions from the market for testing. to this end, dh's public health laboratory will provide necessary technical support.
meanwhile, 20 samples of the line of products produced in the affected manufacturing plant bought by dh from the local market are being tested for sterility. results are expected to be available in 3-weeks' time.
dh appealed contact lens users to stop using solutions of the affected lots. they should consult their doctors in case of discomfort or infection and may also call the manufacturer's hotlines at 2401 5811/ 2 in case of queries.
contact lens users are reminded to observe good hygiene in handling the lens, solutions and utensils to prevent contact lens associated infection. details can be found in chp's website ( http://www.Chp.Gov.Hk/ )
under the consumer goods safety ordinance, it is an offence to supply, manufacture or import into hong kong consumer goods unless the goods comply with the general safety requirement for consumer goods.
the maximum penalty for the offence is a fine of $100 000 and an imprisonment for one year on first conviction, and $500 000 and two years' imprisonment on subsequent conviction.
for complaints regarding unsafe consumer goods, consumers can contact the consumer protection and prosecution bureau, customs and excise department on the 11th floor, north point government office, 333 java road, north point or call the customs hotline at 2545 6182.
ends/thursday, november 23, 2006
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Dh closely monitoring safety of lifescan blood glucose meter the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company was following up whether the lifescan onetouch ultra blood glucose meters supplied to hong kong were of the same design and software as those available in united kingdom.
a dh spokesman said that the unit of measurement of some meters of this model in united kingdom might change from mmol/l to mg/dl if the meter was dropped or if the battery was changed when the meter was switched on.
the spokesman said, "as a precautionary measure, users of any brands of blood glucose meters should always check and ensure that the unit of measurement is in mmol/l in every test. if the unit of measurement is in mg/dl, they should immediately contact their suppliers."
"members of the public are advised to follow strictly instructions in the manual when using blood glucose meters."
the spokesman said that dh had informed the public and private hospitals, nursing homes, medical professional associations, and diabetes patient support groups about this safety issue.
dh has not received any report of adverse events related to the unit of measurement issue, he added.
relevant information has also been posted on the mdco website http://www.Mdco.Gov.Hk/english/recalls/recalls.Html .
ends/tuesday, december 19, 2006
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Advisory notice on use of heartbeat regulating products the department of health (dh) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds).
the notification from boston scientific hong kong limited involved the following products –
a subset of contak renewal 3 & 4 families of crt-ds and
a subset of the vitality and vitality 2 families of icds.
it was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products.
so far 19 of approximately 73,000 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any reported deaths or serious injuries resulting from the problem, both overseas and locally.
according to the boston scientific hong kong limited, in hong kong , 15 devices have been implanted in hospitals under hospital authority (ha) and three in private hospitals. boston scientific has contacted ha and related doctors to advise them to follow up with patients in their clinics as soon as possible.
individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call boston scientific hong kong limited's hotline at 2960 7128 or visit boston scientific's website at http://www.Guidant.Com/ppr/advis/2007_04_05.Shtml for further details about the notification.
the dh has informed public and private hospitals, and medical professional associations about this notification and advised them to take necessary follow up actions.
ends
friday, april 13, 2007.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of medical device for treatment of temporary stoppage of breathing during sleep (cpap machines) the department of health (dh) today (april 25) alerted the public, in particular, the medical community in hong kong, about a worldwide voluntary recall of a number of cpap machines (flow generators), a medical device for treating obstructive sleep apnea (temporary stoppage of breathing during sleep), due to a potential danger of short circuit in the power supply connector which may result in device failure or fire.
the recall, announced by its manufacturer, resmed, involves about 300 000 generators called s8 continuous positive airway pressure (cpap) unit. about 360 of them were sold in hong kong.
a dh spokesman said the department has alerted the hospital authority, the private hospitals, the nursing homes, and medical professional institutions of the recall today.
he said that affected users using cpap units with supplemental oxygen should immediately stop using the device and contact resmed hong kong ltd. for a replacement of the affected parts. other affected users should follow the manufacturer's advice and contact resmed hong kong ltd. for equipment rectification.
a hotline 2366 0707 has been set up by the company to answer enquiries during office hours (monday - friday: 10:00 am - 6:00 pm ; saturday: 10:00 am - 4:00 pm ).
patients are reminded to be extra cautious in using the device and take the following safety measures:
to make sure that the device is placed on a hard clean surface and that the area around the device is clear during use; and
to discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell.
according to resmed hong kong ltd, the company is notifying all affected patients/users to provide advice and for replacement of the device parts.
according to the manufacturer, the potential for a short circuit in the power supply connector is less than 0.2%. in the seven cases reported worldwide, device failures have led to thermal damage to the device, with a remote potential to ignite material external to the device. there are no reports of significant property damage or patient injury arising from this issue.
dh has not received any report of untoward incidents in hong kong arising from this issue.
members of the public may visit http://www.Resmed.Com/en-us/s8program/s8program.Html for more information.
this recall includes s8 cpap units falling within the following serial number ranges: (i) 20040285613 to 20060269563, (ii) 20060275728 to 20060276751, (iii) 20060277160 to 20060277415, (iv) 20060281672 to 20060281991, (v) 20060283424 to 20060283743, (vi) 20060284896 to 20060285445, (vii) 20060287568 to 20060290823, (viii) 20060292360 to 20060294694, (ix) 20060312361 to 20060312597, (x) 20060318692 to 20060319459, (xi) 20060325074 to 20060327794, (xii) 20060330588 to 20060331043.
affected devices can be identified by the serial numbers on the bottom of each device.
nds/wednesday, april 25, 2007.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of amo contact lens solution consumers of amo complete moistureplus contact lens solution are urged to stop using the product immediately following a voluntary recall of the product by its manufacturer, advanced medical optics (amo).
the recall was initiated by amo following reports of acanthamoeba keratitis cases, a rare but serious infection of the cornea, in the united states . "dh is closely monitoring the recall," a spokesman of the department of health (dh) today (may 26) said.
information provided by the local importer of the product, amo asia limited, showed that recall action is in progress to take off the product from the shelf at the retailer level and to operate a hotline for enquiries.
the spokesman said, "contact lens wearers should discontinue using the product immediately and consult their doctor if they have eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye and excessive tearing or other eye symptoms."
he said that dh would liaise with the hospital authority and private eye doctors for more information and to step up surveillance on the associated eye infection.
the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection:
always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time.
the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
close all bottles of contact lens solution properly after use.
discard contact lens solutions after one month of opening.
storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
all contact lenses, solutions and accessories should be stored in a cool and dry place.
disinfect the case weekly by soaking in just-boiled water for 10 minutes.
replace case every three months.
disposable contact lenses must not be used beyond their recommended disposal period.
do not wet your lens with saliva, bottled water or tap water.
remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.
ends
saturday, may 26, 2007.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Medical device alert for blood glucose meters the department of health (dh) was notified by the food and drug administration of the united states today (september 11) about a worldwide medical device alert on a type of blood glucose meters, the display screen of which may not work properly when dropped onto a hard surface.
a dh spokesman said the alert was initiated by the manufacturer, abbott diabetes care, involving blood glucose meters manufactured after january 2007.
the display screen of the affected meters, marked as "abbott optium xceed", may not work properly or may appear blank if dropped on a hard surface, thus making the users unable to view the blood glucose test results.
it was revealed that a total of 857 affected devices were sold in hong kong but none of them were released to hospitals.
as a precautionary measure, users should not use the blood glucose monitor if the display shows missing or blank section. they should contact the local agent or supplier for replacement.
"users should ensure a full display show each time the blood glucose monitor is turned on, especially before using the monitor to check the blood glucose level," the spokesman said.
the spokesman said dh had alerted the hospital authority, private hospitals, nursing homes and medical professional associations to this medical device correction.
dh has not received any report of adverse events arising from this issue.
the spokesman said members of the public using the meters concerned should contact the local agent by calling its hotline 2806 4488 during office hours for advice.
relevant information is available at the manufacturer's website.
ends/tuesday, september 11, 2007
nnnn.