Events

Alerte De Sécurité sur FindrWIRZ Guidewire System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medimaps.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-11-23
  • Date de publication de l'événement
    2016-11-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161123.html
  • Notes / Alertes
    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: sentreheart findrwirz guidewire system medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the united states food and drug administration (fda) has issued medical device safety alerts concerning findrwirz guidewire system, manufactured by sentreheart [product code: 40-05; lot numbers: 01160568, 02160568 and 07160639-150; manufactured between 4 january and 22 july 2016]. the manufacturer is recalling the findrwirz guidewire system because the polytetrafluoroethylene (ptfe) coating may separate (e.G. peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. coating separation may be caused by issues with the device design or manufacturing processes. small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death. affected users are recommended to take the following actions: identify and stop using the affected products. return the affected products to the manufacturer immediately. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm530413.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm530336.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 november 2016.

Device

FindrWIRZ Guidewire System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SentreHEART FindrWIRZ Guidewire System
  • Manufacturer
    Medimaps

Manufacturer

Medimaps
  • Source
    DH