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 suspension of defibrillation leads the department of health (dh) today (october 15) received a notification from a medical device manufacturing company concerning its decision to voluntarily suspend the worldwide distribution of four models of implantable defibrillation leads (components of a device to regulate a patient's heartbeat) due to the potential for lead fractures.
the notification from medtronic international ltd involved the sprint fidelis family of implantable defibrillation leads. the four models are 6930, 6931, 6948 and 6949.
according to the company, over 200 such leads have been distributed to hong kong . so far, dh has not received any report of death or injury in hong kong associated with the devices. dh will closely monitor the development.
dh has alerted the hospital authority, the private hospitals and the medical professional institutions of the notification and advised them to check with the supplier.
according to the company, lead fractures may present as audible alerts, inappropriate shocks and/or loss of output. individual patients who think they may have been implanted with the devices in question should contact their attending doctors.
doctors are advised to immediately stop implanting the devices and contact the company for more information on how to follow-up with patients who have implanted with the leads concerned.
the manufacturer did not recommend immediate replacement of the leads in all patients except in very unusual circumstances.
patients may call the medtronic international ltd's hotline at 2907 5911 from 9:00 am to 5:30 pm on monday to friday for details about the notification.
ends/monday, october 15, 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 blood glucose meters with incorrect readings (i-sens model caresens ii) the department of health today (april 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (bgm)which displayed falsely low readings.
dh immediately looked into the case upon receiving notification from an informant that two bgm manufactured by i-sens inc, were found to display falsely low readings.
it was revealed that only one specific lot (lot no. isp11e02101 – isp11e02600) of the bgm was affected.
the manufacturer, i-sens inc, has initiated a voluntary recall through its distributor, bioscan ltd.
according to bioscan ltd, there were 150 bgm of the affected lot imported to hong kong and 106 bgm to macao respectively.
dh has notified the health bureau of macao of the recall.
users should not use the blood glucose meters of the affected lot and seek advice from their doctors.
the department has not received any report of adverse events arising from this issue.
dh will closely monitor the recall.
the spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement.
ends/thursday, april 23, 2009.
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 device containing non-sterile radioactive material
the department of health (dh) received notification from a medical
device manufacturing company about its voluntary recall of a batch
of radiodiagnostic device which has failed the sterility test.
according to the company- uk ge healthcare, the involved batch
was known as drytec tc-99m generator lot number 5666. there was
a possibility of infection if the non-sterile product was injected
into patients.
the device is used to prepare radioactive material for injection
to patients during radiodiagnostic procedures.
information available showed that the affected lot had been used
in tuen mun hospital and hong kong sanatorium and hospital. so far,
no adverse effect associated with the use of device has been received
by dh.
the dh has informed the hospital authority, private hospitals,
radiodiagnostic laboratories and medical professional associations
about the recall and advised them to check for details with the
company.
dh will continue to monitor the situation and advise the public
and health profession accordingly.
ends/wednesday, april 23, 2008.
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 automated external defibrillators
the department of health (dh) today (april 24) alerted the public of a voluntary recall by the manufacturer of two models of automated external defibrillator (aed) which have switch problem.
the affected models are heartstart mrx/mrxe m3535a and heartstart xl m4735a.
investigation conducted by the manufacturer, philips healthcare, revealed that failures are more likely to occur in devices that have been exposed to high heat and humidity, which contribute to accelerated internal degradation of switch components over time.
about 270 aed of the two models have been introduced to hong kong, mostly to public and private hospitals. philips healthcare has alerted its purchasers.
people should not use the aed of the affected models and contact the company by calling its hotline 2876 7578 for advice.
dh has not received any report of adverse events arising from this issue and will closely monitor the recall.
ends.
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 kappa and sigma pacemakers
the department of health was informed by medtronic international ltd. yesterday (may 18) that the company was following up on some medtronic kappa and 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.
the affected devices comprised kappa 600/700/900 and sigma 100/200/300.
patients are recommended to consult their doctors immediately if they experience fainting or lightheadedness. there is no reported patient injury or death associated with this failure in hong kong so far.
the hospital authority and private hospitals have been informed of this follow up action. there are totally 189 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.
end/tuesday, may 19, 2009.
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
Heartbeat regulating products with low-voltage problem 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).
a dh spokesman said, the notification from medtronic international limited involved the products, a subset of concerto crt-d and a subset of virtuoso icd. 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 230 of approximately 6,300 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any report ed deaths or serious injuries resulting from the problem, both overseas and locally.
according to the medtronic international limited, in hong kong , three devices have been implanted in hospitals under hospital authority (ha). medtronic has contacted ha and related doctors to advise them how to address the problem .
the spokesman said, individual patients implanted with affected devices should follow their scheduled appointments for follow up. however, they should contact their attending doctors immediately if receive an alert tone coming from their implanted device .
patients may call medtronic international limited's hotline at 2919 6413 for further details about the notification .
the dh has informed public and private hospitals, and medical professional associations about this notification and advise d them to take necessary follow up actions.
ends/tuesday, september 8, 2009.
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
Field correction of automated external defibrillators the department of health (dh) today (november 18) alerted the public of a voluntary field correction by the manufacturer and supplier of two series of automated external defibrillator (aed)which may fail to deliver therapy during a resuscitation attempt.
the affected models are powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, and cardiovive 92531, 92532 and 92533.
the manufacturer, cardiac science corporation, estimated that one in 75,000 aeds manufactured between august 2003 and august 2009 may suffer the failure.
a software update will be available by may 2010 to fix the problem.
the company advises users to keep their aeds in service and follow the normal testing and maintenance procedures.
about 262 aed of the two series of models have been sold to 157 users in hong kong.
the local sole supplier of the affected aed, pacific medical systems ltd, could be contacted at 2108 4005 for advice.
“users should follow the recommendations of the manufacturer and make contingency provisions in case the aed could not deliver therapy,” a spokesman for the department said.
“the department had alerted the hospital authority, private hospitals, nursing homes, relevant institutions and medical association of the voluntary field action.
“so far, no reports on adverse events arising from this issue have been received.
“the department will closely monitor this field correction,” he said.
ends/wednesday, november 18, 2009.
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 lifescan onetouch surestep blood glucose test strips with incorrect readings the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company had initiated a voluntary recall of blood glucose test strip which may provide low readings.
only one affected lot (lot number 2966727) of lifescan onetouch surestep test strips was supplied to hong kong.
the affected test strips may provide low test results when the blood glucose level is greater than 22.2mmol/l, a dh spokesman said.
"a total of 2,160 boxes of the lot have been imported to hong kong. among them, 2,116 unsold boxes have already been retrieved from the market. only 44 boxes have been sold in hong kong," the spokesman said.
the dh has not received any report of adverse events arising from the test strip.
members of the public should stop using the affected product and contact the company at hotline 3128 8101. it will operate daily from 9am to 6pm including the chinese new year holidays.
the department will closely monitor the recall.
ends/friday, february 12, 2010.
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 silicone-filled breast implants the department of health (dh), through its routine surveillance today (march 31), found that a french regulatory authority has announced a recall of the silicone-filled breast implants manufactured by poly implant prothese (pip).
the affected models include imghc-tx, imghc-mx and imghc-ls.
there is an increase of reported adverse events concerning the problematic products in the past three years. they are mainly breakings and local complications.
despite the fact that the products are not listed with dh, the department considered that there may be quality defects and safety concerns of the products after risk assessment.
dh decided to inform stakeholders including hospital authority, hospitals and medical professional association about the recall.
information on the recall has been posted on the dh's website.
members of the public who have implanted with the affected products, or in case of doubt, should consult their doctors.
the dh has not received any report of adverse events arising from the affected products.
the department will closely monitor the developments of the recall.
ends/wednesday, march 31, 2010.
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 defects cause malfunctioning in medtronic's implantable cardiac devices the department of health (dh) today (may 5) received notification from medtronic international limited (mil), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning.
a dh spokesman said, the affected models are consulta crt-d (d234trk), secura dr/vr (d234drg, d234vrc), maximo ii crt-d (d284trk) and maximo ii dr/vr (d284drc, d284vrc). all except maximo ii vr (d284vrc) are distributed in hong kong.
as of april 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide. however, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far.
here in hong kong, mil's record shows that a total of 40 affected devices have been implanted in patients of either hospital authority or private hospitals.
mil recommends no change to current patient management. the devices will receive software updating upon the patients’ next scheduled clinic follow-up. the company is contacting physicians concerned individually.
the spokesman does alert patients who have the deficient implants that if they experience cardiac symptoms or hear alerts from the devices, they should seek medical attention immediately.
patients can call mil’s hotline at 2919 6413 for further details.
meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with mil on further development, if any.
ends/wednesday, may 5, 2010.
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 defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd).
the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it.
according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007.
no patient injury or death has been reported worldwide.
patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details.
a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell.
meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any.
end/thursday, may 6, 2010.
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 automated external defibrillators
the department of health (dh) today (june 1) drew public attention to a voluntary recall by the philips electronics hong kong ltd. of four models of automated external defibrillators (aeds) which may have voltage detector problems.
the affected models are heartstart fr2+ m3860a, m3861a, m3840a and m3841a.
investigation conducted by the manufacturer revealed that the units may contain a component called a voltage detector from lots that have a higher than expected rate of failure, which can cause the aed battery to drain more rapidly than normal or to render the aed unusable.
according to philips electronics hong kong ltd, a total of 46 units of the affected models of aeds have been sold to clinics, medical professional organisations and commercial organisations and the company has alerted its purchasers.
those who possess the affected models should contact the company by calling its hotline 2876 7578 for advice.
dh has not received any report of adverse incidents arising from this issue and will work closely with the company to monitor the recall.
1 jun 2010.
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 defect may cause malfunction in implantable cardioverter-defibrillator
the department of health (dh) today (june 9) received notification from a local supplier, innotronik hong kong limited (innotronik), about a software problem in three models of implantable cardioverter-defibrillators (icds) manufactured by sorin in italy.
the affected 3 models are paradym dr 8550, crt 8750 and crt sonr 8770.
the problem is due to a rare software anomaly when dual-chamber backup pacing (i.E.Pacing to both heart atrium and ventricle) is applied.
according to the supplier, approximately 2,800 units have been implanted worldwide.
as of 7 june this year, sorin has received one confirmed report of defect. no patient injury or death has occurred as a result of the identified software anomaly.
according to innotronik, a software update will eliminate this risk. the new software will be updated to the patient's icd in the next scheduled check-up.
innotronik informed that three paradym dr 8550 icds have been implanted as single chamber backup pacing in hong kong. the risk of these patients being affected by this software anomaly is low.
innotronik has set up a hotline (tel no. 2877 6787) for enquiries.
a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell.
meanwhile, the dh will inform public and private hospitals, medical associations and healthcare professionals and will also follow up with innotronik on further developments, if any.
ends/wednesday, june 9, 2010.
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
Caution on novabel dermal filler
the department of health (dh) has drawn public attention to reports of adverse reactions as a result of using novabel dermal filler, an implantable material for reconstruction and body contouring.
dh, through its routine surveillance, found that the uk's medicines and healthcare products regulatory agency (mhra) announced that a manufacturer in germany had issued a notice to advise clinicians not to use novabel because of the dissatisfactory aesthetic outcome. the agency is assessing the adverse reactions.
the affected products included all batches of novabel, dermal filler (1x1ml, art.-nr. 40800) and novabel, dermal filler (2x1ml, art.-nr. 49021).
according to the manufacturer, an overall number of 70 cases of
adverse reactions were reported from about 24,000 syringes sold. the reactions included redness, bruising, pain and swelling. some patients had visible and palpable nodules and indurations. many of these have
resolved since being reported.
while dh is obtaining more information from mhra, as precautionary measures, dh has informed healthcare professionals of hospital authority, private hospitals, and relevant medical professional associations about the alert.
the spokesman said members of the public who have these reactions after using the concerned product should consult their healthcare providers.
dh will monitor future developments.
ends/saturday, july 31, 2010.
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 automated peritoneal dialysis system
the department of health (dh) received a notification from baxter healthcare limited (hong kong) (baxter) this afternoon (august 11) that it would organise with customers the return and replacement of an automated peritoneal dialysis system, homechoice (product code: 5c4474).
baxter explained that the arrangement was necessary because the required final tests and calibration of the product model had not been performed, a spokesman for the department said.
through network searching, the dh also noticed that the us food and drug administration (fda) had actually issued an alert earlier on this year concerning reports of serious injuries and at least one death linked to increased intraperitoneal volume (iipv) associated with the use of the same model.
iipv can cause serious breathing and heart problems which can result in serious injury or death.
in addition, children and nonverbal patients may be at increased risk because of their smaller abdominal cavities or inability to communicate.
according to baxter, at least 186 homechoice devices had been affected in hong kong.
so far, the dh and baxter have not received any report of adverse events related to this issue.
taking into account the information available, dh is concerned with possible safety, efficacy and quality of the product, he said.
while seeking further clarification from fda and the baxter of two events, dh in fact instructed baxter to recall and replace the device concerned.
"patients using the device are urged to contact their attending doctors immediately," the spokesman said.
"as an interim, clinicians are advised to balance the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy.
"they should also review the prescription settings for patients who continue to use these devices," he said.
baxter's local supplier has set up a hotline, 6113 1063, for public enquires.
the dh will closely monitor the progress of the recall.
ends/wednesday, 11 august 2010.
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 single-use contact lenses
the department of health (dh) was notified by johnson & johnson (hk) limited today (august 19) that a voluntary recall of 16 batches of contact lens 1 day acuvue trueye is underway due to potential eye irritation or discomfort as a result of using the product.
a dh spokesman said the affected batch was manufactured in ireland with lot numbers - 492237, 492238, 492241, 492245, 492250, 492251, 492252, 492254, 492268, 492280, 492281, 492282, 492283, 492287, 492288 and 492289. these numbers are the first six digits of the lot number printed at the side of the product box.
according to johnson & johnson, the recall followed complaints regarding "unusual stinging or pain upon inserting of lens" reported in japan, which included stinging, ocular pain, redness and irritation.
the investigation of the manufacturer so far showed that there was a problem in one portion of the lens rinsing process on a particular manufacturing line during a certain period of time.
in hong kong, there has so far been no reported adverse events arising from use of the affected batches. according to the local supplier, about 3,715 boxes of the affected batches have been shipped out to optical outlets.
the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2963 6799, for recall and product replacement.
the hotline will operate from august 20 until september 22, daily between 9am and 6pm. the recall details can also be accessed at the website: www.Acuvue.Com.Hk.
those who feel unwell after using the product should seek advice from their healthcare professionals.
meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue.
the recall will be closely monitored.
ends/thursday, august 19, 2010.
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
Contact lens problems
in response to media enquiries, a spokesman for the department of health (dh) said information provided by johnson & johnson (hk) limited indicated that the problem of its 1 day acuvue trueye which led to a recall of 16 batches of the product was caused by failure to remove a diluent during the rinsing process.
according to johnson & johnson,the affected lots may contain lenses with trace amount of diluent agent that is intended to be extracted from the lens during the rinsing process. due to a mechanical failure in the rinsing process this extraction was not complete. this diluent agent is an intended part of the 1day acuvue trueye formulation and therefore is not considered a contaminant.
in relation to the recall, the spokesman added that johnson & johnson had been asked to deploy more staff to man its enquiry hotline and speed up recall and product replacement.
the spokesman said: "dh's investigation continues and the recall will be closely monitored."
20 august 2010.
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
Further recall of single-use contact lenses
further to the voluntary recall of contact lens "1 day acuvue trueye" announced on august 19, the department of health (dh) was notified by johnson & johnson (hk) limited today (october 27) that the company is extending the recall lots of the product.
a dh spokesman said the affected batch was manufactured in ireland with lot numbers falling between 492237 and 492498 and between 502080 and 502269, which include the 16 batches of product announced on august 19. these numbers are the first six digits of the lot number printed at the side of the product box.
according to johnson & johnson, detailed investigation into the incident in august revealed that the lens rinsing process on two production lines did not meet the internal production standards of the company, leading to a residual trace amount of diluent in the lenses.
in hong kong, there has so far been no reported adverse event arising from use of the affected lots. according to the local supplier, 11 800 boxes in additional to the 3715 boxes of the affected lots announced on 19 august are affected in hong kong.
the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2512 2112, for recall and product replacement.
the hotline will operate from today onwards between 9am and 6pm from monday to friday. the recall details can also be accessed at the website, www.Acuvue.Com.Hk.
those who feel unwell after using the product should seek advice from their healthcare professionals.
meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue.
the recall will be closely monitored.
ends/wednesday, october 27, 2010.
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 abbott's glucose test stripsthe department of health (dh) has directed local supplier abbott laboratories limited to recall 359 lots of glucose test strips which may give falsely low blood glucose results today (december 23).
the recall followed assessment of a us food and drug administration (fda) alert, captured by dh's routine surveillance system, which involved the recall of 359 different lots of glucose test strips marketed by abbott diabetes care in the us under the following brand names:
* precision xceed pro;
* precision xtra;
* medisense optium;
* optium;
* optiumez; and
* relion ultima
the blood glucose monitoring systems are not affected by this recall.
more details of the recall are posted under fda news (medical devices) and the abbott diabetes care respectively:
http://www.Fda.Gov/newsevents/newsroom/
pressannouncements/ucm237900.Htm
http://www.Precisionoptiuminfo.Com/img/lot-numbers.Pdf
according to initial information from the local supplier, at least the following items and lot numbers in the list of test strips are available in hong kong:
medisense optium blood glucose electrodes
* lot 45001a137
* lot 45001a921
precision xceed pro blood glucose test strips
* lot 44cr5h
abbott's records revealed that some 6,000 boxes of the above lots are available in hong kong.
a spokesman for dh said although records showed that only three lots were shipped to hong kong, it was necessary to recall all 359 lots of products as some products might have been directly brought back to hong kong by consumers or purchased over the internet.
so far, the dh has not received any report of adverse events arising from the affected products.
members of the public should stop using any of the 359 lots of products and contact healthcare professionals if in doubt.
they may contact the company at hotline 2806 4488 daily from 9am to 5pm for recall arrangements.
hospitals, medical associations and nursing homes have been alerted. the department will closely monitor the recall. investigation continues.
thursday, december 23, 2010.
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
Blanket recall of abbott glucose test strips the department of health (dh) has today (december 29) requested a local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers as a further precautionary measure to safeguard public health.
a spokesman explained that further to the recall of 359 lots of abbott's glucose test strips under six brand names announced on december 23, dh noted that the recall list of abbott glucose test strips in the us has been expanding over the holiday to some 10 brands, involving over 380 lots.
meanwhile, singapore's health sciences authority issued another recall list of 43 lots under the brand name of "abbott medisense optium blood glucose test strips", some lots of which are also on the us' latest list above.
"in view of uncertainties at this stage over the exact number of brands and lots affected, dh requested abbott to recall all their test strips from the hong kong market in order to be vigilant. consumers are advised to stop using any abbott glucose test strip they have in hand immediately as the strips may show lower than actual readings. high blood sugar poses health risks and can be life threatening", the spokesman said.
"consumers can contact the company's 24-hour hotline at 8302 0507 on recall arrangements. whenever in doubt, they may also consult their healthcare workers for individual advice."
29 dec 2010.
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
Resumption of sale of abbott's optium omega glucose test stripsthe department of health (dh) has today (january 11) agreed to allow one brand of abbott's glucose test strips, optium omega, to re-enter the market.
a spokesman for dh said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of optium omega and the supply of alternatives on the market.
dh, through its routine surveillance system, captured a us food and drug administration (fda) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by abbott diabetes care in the us late last december.? this is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.?
to allow time for proper investigation and as a precautionary measure to safeguard hong kong's public health, dh requested the local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers on december 29 last year.
"as optium omega's unique design and manufacturing could ensure its exemption from ineffectiveness, dh thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in hong kong," a dh spokesman explained.
"however, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked.
dh would continue to follow-up with the investigation and also closely monitor the recall of other brands of abbott’s glucose test strips.
ends/tuesday, january 11, 2010.
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
Serious safety concern on some medico implantable pacemakersthe department of health (dh) today (january 27) warned the public that a group of implantable pacemakers run the serious risk that they may not function.
dh, through its routine surveillance on medical devices, noticed that uk's medicines and healthcare products regulatory agency (mhra) has made an alert on a report by the italian manufacturer medico that a group of its implantable cardiac stimulators, sophos 151, sophos 155 and helios 300, might fail to function. medico discovered this during a routine follow-up and on analysis of sophos 151 pacemaker serial number mdaa473, found that the malfunctioning was because of intermittent instability of the electrical continuity of some inner substrate connections.?
a dh spokesman remarked that although the incidence of failure is low, quoted to be 0.013%, and thus far there is neither record of marketing or report of field event in hong kong, the dreaded consequence and that there may be occasional patients here who have somehow obtained the devices overseas are what cause the publication of this statement.?
the serial numbers of the medico pacemakers involved are -
a)? sophos 151, serial numbers from mdaa378 to mdaa383, from mdaa385 to mdaa411, from mdaa413 to mdaa421, mdaa423, mdaa424, from mdaa426 to mdaa448, from mdaa450 to mdaa464, from mdaa466 to mdaa472, from mdaa474 to mdaa483, from mdaa496 to mdaa506;
b)? sophos 155 with serial numbers from mdfa222 to mdfa234, from mdfa236 to mdfa312; and
c)? helios 300 with serial numbers from mb3a111 to mb3a120.
while dh will continue to check with medico and mhra about the export of the incriminated products to hong kong besides monitoring the development of the issue, the spokesman said: "any member of the public who have been implanted with any of the affected products should consult their healthcare workers for advice as soon as possible".
meanwhile, dh has also informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.
ends/thursday, january 27, 2011.
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 concern on fraxel re:store dual laser systemthe department of health (dh) today (february 11) warned healthcare professionals and beauty industry operators that the fraxel re:store dual laser system runs the risk of causing inadvertent laser firing which may lead to patient/operator injury.
dh, through its routine surveillance on medical devices, noticed that the us food and drug administration (fda) has announced that the product’s manufacturer, solta medical inc., is recalling all the affected devices for corrective actions.
fraxel re:store dual laser system is a laser surgical instrument for use in general and plastic surgery and in dermatology.
a dh spokesman said: "there is a risk of causing skin burn under high energy setting and small spot size."
the model numbers and serial numbers of the devices involved are -
model numbers:
mc-sys-sr1500-d-us; mc-sys-sr1500-d-us-loaner;
mc-sys-sr1500-d-upg-us; mc-sys-sr 1500-0-1 ntl;
mc-sys-sr1500-d-i-loaner; mc-sys-sr1500-d-upg-intl
serial numbers:
f1196j, j0007, j0010-j0058, j0060-j0203, j0205, j0207-j0209, j0211-j0337, j0339-j0359, j0361-j0414, j0417-j0419, j0426
according to the information from local supplier, solta medical inc., at least three machines were imported to hong kong. two were sold to local healthcare professionals and one was used as a demonstration machine. the supplier has contacted the local users for immediate corrective actions.
so far, the dh has not received any report of adverse events arising from use of the affected products.
dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.
while dh will continue to monitor the development, the spokesman urged healthcare professionals and operators of beauty parlours who are using the affected device to stop using it, and contact the local supplier for immediate corrective actions.
ends/friday, february 11, 2011.
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 alert on accu-chek flexlink plus infusion sets
the department of health (dh) today (march 2) warned the public not to use accu-chek flexlink plus infusion sets, manufactured by roche diagnostics (roche), because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set.
the dh, through its routine surveillance of medical devices, noticed that roche has announced a recall of the above product. roche's investigation into complaints regarding kinked cannulas revealed that in some cases the distance between the needle cut and the end of the soft cannula is too small and may contribute to an impaired cannula.
the malfunction of infusion sets may result in under delivery of insulin leading to elevation of blood glucose levels, or hyperglycemia. symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue and headache.
a dh spokesman remarked that hyperglycemia is a significant health risk, as untreated hyperglycemia may lead to death in serious cases. although preliminary investigation has revealed that there is neither record of marketing of the product nor report of such adverse events in hong kong, the potentially serious consequences and the fact that there may be occasional patients here who have somehow obtained the devices overseas justify a public alert.
roche diagnostics (hong kong) ltd has set up a hotline, 2485 7512, to answer public enquiries from 9am to 12 noon, and from 2pm to 5pm between monday and friday.
meanwhile, dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.
the spokesman said: "dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt or feel unwell."
ends/wednesday, march 2, 2011
issued at hkt 16:35.
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 microbial contaminated protective wipes and adhesive removers
annex
the department of health (dh) today (april 15) endorsed a local medical device supplier, smith & nephew (s&n) ltd's proposal to recall eight types of its devices imported from the states (see annex) because of a potential for pathogenic contamination.
a dh spokesman explained that the eight products belonged to two categories. the first comprises five types of protective wipes, used for skin preparation before the removal of tapes and films. the second consists of three types of adhesive removers which can clean adhesive residues from the skin.
the spokesman said, "s&n's initiation comes following the dh's earlier call this january, advising the public not to use a us manufacturer, triad group's alcohol swab preparations after the us food and drug administration's blanket market recall of the items because of the potential risk of contamination by a bacterium, bacillus cereus. at the same time, local medical device traders are advised to check if any of their products have been affected as a consequence."
bacillus cereus is known to be able to cause life-threatening infections among at-risk populations, including surgical and immuno-compromised patients. thus far however, the dh has not been notified of any such infections.
s&n alerted the dh that its parent company in the states, smith & nephew inc, has just announced a global recall on the above eight products as the items were also manufactured by the triad group and have been found to have the same risk of contamination by bacillus cereus.
the spokesman remarked that in fact s&n had only imported the first two items in the table, remove universal adhesive remover wipes and skin-prep protective wipes for sale in hong kong. therefore, the two would be the major targets of s&n's present recall.
"however, mindful of the option of internet trading and also the possibility of possession by travellers, return of any of the other six items would also be handled," the spokesman clarified.
a hotline 2648 7770 has been set up by s&n for related enquiries.
the spokesman finished by stating that while dh will continue to monitor developments of the triad group recall and s&n's related act in hong kong, patients and healthcare providers are advised to stop using products under recall in hand immediately. they may choose substitutes from alternatives available on the market.
ends/friday, april 15, 2011
issued at hkt 19:25.