Events

Alerte De Sécurité sur Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing

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 Medical Systems B.V.

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
    2013-01-10
  • Date de publication de l'événement
    2013-01-10
  • 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_20130110.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, winged infusion sets, and psi‐tec tubing the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning mentor breast implant, winged infusion sets, and psi‐tec tubing , manufactured by mentor medical systems b.V. the manufacturer has identified an issue where some lots of these products were inadvertently shipped out beyond their expiration date because of a scanning error in the company’s inventory and distribution system. some of the lots 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. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con216883 if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 january 2013.

Device

Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing
  • Manufacturer
    Mentor Medical Systems B.V

Manufacturer

Mentor Medical Systems B.V