Events

Alerte De Sécurité sur Silimed medical devices (all - including 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 Silimed.

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
    2015-09-25
  • Date de publication de l'événement
    2015-09-25
  • 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_20150925.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: silimed medical devices (all - including breast implants) the therapeutic goods administration (tga) of australia posted a medical device safety alert concerning all medical devices manufactured by silimed. the tga is aware that european union (eu) health regulators have suspended approval for all devices manufactured by the brazilian company silimed following an inspection of a manufacturing site. silimed's ce certificate was suspended after german health officials inspected silimed's manufacturing plant and found that the surfaces of some devices were contaminated with unknown particles. in general, a medical device cannot be marketed in europe without carrying a ce mark of conformity. as a precautionary measure and in consultation with the tga, the australian distributor has been contacting surgeons who have been supplied with these implants to recommend any planned implant surgeries be postponed. the tga has had no adverse event reports relating to these products and there has been no indication that these issues would pose a threat to the implanted person's safety. for details, please refer to the following link:http://www.Tga.Gov.Au/alert/silimed-medical-devices-all-including-breast-implants if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 25 september 2015.

Device

Silimed medical devices (all - including breast implants)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Silimed medical devices (all - including breast implants)
  • Manufacturer
    Silimed

Manufacturer

Silimed