Events

Alerte De Sécurité sur Mentor breast implants

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

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
    2013-05-21
  • Date de publication de l'événement
    2013-05-21
  • 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_20130521b.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: mentor breast implants the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning breast implants manufactured by mentor. the affected sales code and lot number are 3545160 and 5741158 respectively, with expiry date in may 2012. the manufacturer has identified an issue where one lot of these products was inadvertently shipped out beyond its expiration date because of a scanning error in the company’s inventory and distribution system. the affected lot may contain a secondary inventory label with an incorrect expiry date (different from the product label). to date, no complaints have been reported that are connected to this issue. the manufacturer advises users to immediately identify and quarantine all unused product and return them to their supplier for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con273701 if you are in possession of the product, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

Mentor breast implants
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Mentor breast implants
  • Manufacturer
    Mentor

Manufacturer

Mentor