Events

Alerte De Sécurité sur Side Fire Needles, part of Confidence Spinal Cement System™

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

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
    2012-05-16
  • Date de publication de l'événement
    2012-05-16
  • 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_20120516.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: depuy side fire needles, part of confidence spinal cement system™ medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning side fire needles, part of confidence spinal cement system™. during post market surveillance review of the confidence system, the manufacturer has found that the complaint rate for breakage of the side fire needles was higher than the anticipated occurrence rate in the design failure mode and effect analysis. upon evaluation of risk it was determined to reduce the level of risk, a communication would be sent out to all users of the products to reinforce proper technique and instructions for use. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2012.

Device

Side Fire Needles, part of Confidence Spinal Cement System™
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Side Fire Needles, part of Confidence Spinal Cement System™
  • Manufacturer
    DePuy

Manufacturer

DePuy