Events

Alerte De Sécurité sur Cereform silicone gel-filled 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 Cereplas.

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
    2014-02-24
  • Date de publication de l'événement
    2014-02-24
  • 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_20140224.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: cereplas cereform silicone gel-filled breast implants the australia therapeutic goods administration (tga) posted a medical device safety alert concerning cereform silicone gel-filled breast implants manufactured by cereplas. the tga was advised on 13 february 2014 that non-implanted cereform silicone gel-filled breast implants have been recalled in france after the french regulatory authority, agence nationale de sécurité du médicament et des produits de santé (ansm), found the sterilisation process used in the manufacture of these devices had not been fully validated in accordance with the most recent international standard. information from the ansm states that the french recall is being undertaken because of regulatory non-compliance. they have further stated that they have not identified a health risk associated with this issue. in australia, the tga has suspended further supply of these implants until it has finalized its investigation and determined that the implants are safe for use. tga has sought information from ansm and from the french manufacturer so that a decision about further supply of these implants can be made. for details, please refer to the following link:http://www.Tga.Gov.Au/safety/alerts-device-cereform-breast-implants-140221.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 february 2014.

Device

Cereform silicone gel-filled breast implants
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cereplas Cereform silicone gel-filled breast implants
  • Manufacturer
    Cereplas

Manufacturer

Cereplas
  • Société-mère du fabricant (2017)
    Cereplas
  • Source
    DH