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 over lenscare sh-system monatslinsen monthly contact lenses
the department of health (dh) today (november 19) drew public attention to the recall of lenscare sh-system monatslinsen contact lenses because the surface of these lenses can get scratches during wearing and can even break.
the dh, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a notice issued by a german manufacturer, 4care gmbh.
according to the manufacturer, customer complaints for certain lot numbers of the products have increased recently. it was found that the surface of the lenses can get scratches during wearing and can even break. this may lead to foreign body sensation, blurred vision or eye irritation. the manufacturer advised users to stop using the products immediately.
"the dh is following up with the manufacturer in germany to ascertain if the products have been distributed in hong kong. so far, the dh has not received any local reports of adverse events associated with the products," the spokesman said.
"those customers who have purchased the said products should stop using them. they should consult health-care professionals for advice as soon as possible if they are either feeling unwell after using the products or in doubt," the spokesman added.
the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue.
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
Medical Device Safety Alert
Cause
Medical device safety alert: mckesson anesthesia care system
the u.S. food and drug administration (fda) posted a medical device safety alert concerning mckesson anesthesia care system with code number mac 14.3.1/mac 14.3.1.1.
there was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record in that it included data from another case.
for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1060-2014&w=03122014&lang=eng
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 13 march 2014.
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 over genstrip blood glucose test strips
the department of health (dh) today (april 30) drew public attention to a safety alert concerning a glucose test strip called genstrip blood glucose test strips. the test strip, manufactured and sold by shasta technologies llc, may report incorrect blood glucose readings.
the dh, through its routine surveillance on medical devices, noticed the above alert issued by the us food and drug administration (fda). the test strips concerned are advertised for use with the lifescan onetouch family of glucose meters (e.G. ultra, ultra 2 and ultra mini) manufactured by another medical device manufacturer, johnson and johnson.
according to the alert, the fda found extensive violations of relevant regulations intended to assure the quality of products in the manufacturing of the test strips during a recent inspection of shasta technologies llc. as the company did not have in place many of the requirements of a quality system, the fda believes that the strips could report incorrect blood glucose levels.
a spokesman for the dh explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia.
the dh is investigating whether genstrip blood glucose test strips have been imported into hong kong. as the lifescan onetouch family of glucose meters is available for sale locally, there is also a possibility that some patients may have purchased the affected test strips abroad or from the internet for their own use. the dh hence advises the public to stop using the product concerned and switch to alternative blood glucose test strips which are designed for use with the lifescan onetouch family of glucose meters.
so far, the dh has not received any local report of adverse events arising from use of the product.
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
Medical Device Safety Alert
Cause
Medical device safety alert: onetouch ultra 1x50 glucose test strips
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning onetouch ultra 1x50 test strips distributed by chemilines limited in the united kingdom. the affected batch number is 3621702/001 and the expiry date is oct 2015.
the distributor issued a voluntary recall on one batch of onetouch ultra- 1x50 test strips due to an error in the re-packaging process whereby wrong information input in the code box of the primary pack over-label.
the primary pack is covering the code on the original manufacturer’s label related to the reading accuracy of the result. that code should be input by the patient into the meter device for reading confirmation. as a result, the patient may experience difficulties using the product
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 december 2014.
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
Medical Device Safety Alert
Cause
Medical device safety alert: implantable left ventricular assist devices
the united states food and drug administration (fda) has issued a medical device safety alert concerning two implantable left ventricular assist devices (lvads). the affected devices are as follow:-
fda is alerting health care providers, patients, and caregivers about serious adverse events associated with lvads. these adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with thoratec’s heartmate ii and a high rate of stroke with the heartware hvad since approval of the devices. fda is also aware of bleeding complications related to both the thoratec heartmate ii and heartware hvad.
when used for the currently approved indications in appropriately selected patients, fda believes the benefits of these lvads continue to outweigh the risks. however, the fda also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.
for details, please refer to the fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm457333.Htm
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm457327.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 06 august 2015.
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
Medical Device Safety Alert
Cause
Medical device safety alert: inferior vena cava filters
the health canada has issued a medical device alert concerning inferior vena cava (ivc) filters. the manufacturers, models and categories of the affected devices are as follows:
manufacturermodelcategory
‧a.L.Naln vena cava filterretrievable
‧bard peripheral vasculardenali vena cava filterg2 filter systemsimon nitinol vena cava filterretrievableretrievablepermanent
‧b. braun medicalvenatech lp vena cava filter systempermanent
‧cordis casheloptease vena cava filtertrapease permanent vena cava filterretrievablepermanent
‧rex medical, lpoption retrievable vena cava filter systemretrievable
‧william cook, europe aps and cook, inc.Cook celect platinum vena cava filtercook celect vena cava filtergianturco-roehm birds nest vena cava filtergunther tulip vena cava mreye filter setretrievableretrievablepermanentretrievable
as of june 6, 2016, health canada has received 121 incident reports of serious complications associated with ivc filters. these complications have also been reported internationally. serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with ivc filters. many of these complications occurred with long-term (greater than 30 days) filter implantation.
health canada has recently completed a review of the clinical evidence for the safety and effectiveness of ivc filters. although there have been numerous clinical studies of ivc filters, there are only two randomized controlled trials (rcts) of ivc filter use. in both studies, patients with documented venous thrombo-embolism (vte) were randomized to therapeutic anticoagulation alone or to therapeutic anticoagulation plus an ivc filter. results from these two rcts do not support the use of ivc filters in patients who can be treated with anticoagulation. reductions in vte and mortality have not been demonstrated.
health canada is communicating to healthcare professionals that ivc filters are appropriate for patients with certain types of blood clots, who cannot be treated with anticoagulant drugs. health canada is also working with the manufacturers of ivc filters to continue to monitor the post-market safety and effectiveness of ivc filters in canada as well as worldwide.
for details, please visit the following health canada website:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59518a-eng.Php
posted on 26 july 2016.
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
Medical Device Safety Alert
Cause
Medical device safety alert: meditech ultrasound gel
the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning ultrasound probe cover (telescopic folded with gel); and all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. [part number/ order code: 88654012; lot number: 201701].
meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia.
whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. are also affected by this recall.
users are advised that all product labelled meditech and manufactured by yafho bio-technology co ltd and/or linmed medical co ltd, including all stock of ultrasound probe cover (telescopic folded with gel) should quarantined immediately and recalled from the market.
for details, please refer to the tga websites:
http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00631-1
https://www.Tga.Gov.Au/alert/meditech-ultrasound-gel
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 may 2017.
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
Medical Device Safety Alert
Cause
Medical device safety alert: pneumothorax events associated with feeding tube placement systems
the united states food and drug administration (fda) issued a letter to the health care providers about reports of pneumothorax events associated with feeding tube placement procedures using the cortrak 2 enteral access system (eas) by corpak medsystems. most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. several of these events were associated with cardiopulmonary arrest and patient death. although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically < 0.5%, the fda is alerting clinicians that the use of this device does not eliminate this risk and reminding health care providers of important use information for eas systems.
from january 2012 to july 2017, the fda received 51 medical device reports (mdrs) about pneumothorax events related to the use of the cortrak device. these included 11 reports of patient death. the relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. in addition, because the mdr system is based on passive surveillance, the fda cannot determine how the rate of these complications compares to that estimated for blind insertion.
during that same period of time, fda received one report of a non-fatal pneumothorax event associated with the kangaroo feeding tube with iris technology. that event occurred following blind placement of the tube, without use of the video console. the smartrack device is not currently being sold within the united states and no mdrs have been received for this device. no mdrs have been received for the smartrack device this device.
for enteral access systems, the fda recommends:
the device only is used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
the device not be used in patients who have contraindications for naso-enteric feeding tubes in general.
if any resistance is met during placement or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed.
confirmation of the final tube position should be done per institution protocol, in particular if any difficulty occurred during insertion.
for details, please refer to the fda websites:
https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm591838.Htm
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/
ucm592051.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 15 january 2018.
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
Medical Device Safety Alert
Cause
[13 january 2012] field safety notice: terumo® advanced perfusion system 1
medical device manufacturer, terumo® cardiovascular systems corporation, has issued a field safety notice on the use of unauthorized cable for terumo® advanced perfusion system 1.
the manufacturer is aware of some users operating a terumo® advanced perfusion system 1 with a modified cable to connect the system to an occluder for the sarns™ modular perfusion system 8000. the cable is not specified for use with terumo® system 1 and its use in this manner constitutes an off-label use.
the modified cable is not compliant with terumo® system 1 specifications and its use may result in hazardous conditions such as easy dislodgement from the system base resulting in loss of the occluder’s function. it may cause the system to lose electro-magnetic interference protection or create a minor shock hazard in the event of an internal short/failure within the occluder system components.
according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.