Events

Alerte De Sécurité sur Carpentier-Edwards PERIMOUNT heart valves

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

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
    2012-05-29
  • Date de publication de l'événement
    2012-05-29
  • 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_20120529a.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: edwards lifesciences heart valves the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device field safety notice concerning the following heart valves manufactured by edward lifesciences ltd:- carpentier-edwards perimount models 2900, 6900p, and 6900ptfx, carpentier-edwards perimount magna models 3000 and 3000tfx, carpentier-edwards perimount magna ease model 3300tfx, carpentier-edwards perimount magna mitral model 7000tfx, carpentier-edwards perimount magna mitral ease model 7300tfx edwards decided to recall all unused devices with the above model numbers as they discovered that some of the valve jars containing the products may contain one or more small particles. the particles are metallic and were introduced into the valve jars during the packaging process. edwards commented that based on particle size (vast majority <200 microns in size), the small number of particles in any affected jar and the likelihood of the particles being removed during the rinse procedure described in the device’s direction for use, the risk of injury to patients implanted with an affected device is unlikely. according to the local distributor, affected products have been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 29 may 2012.

Device

Carpentier-Edwards PERIMOUNT heart valves
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Edwards Lifesciences Heart Valves
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences