Events

Alerte De Sécurité sur 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
    2013-01-22
  • Date de publication de l'événement
    2013-01-22
  • 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_20130122b.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 confidence spinal cement system medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning all lots of confidence spinal cement system 5cc kit, confidence spinal cement system 7cc kit, confidence spinal cement system 11cc plus kit and confidence spinal cement system kit(catalogue numbers 283905000, 283907000, 283910000 and 283913000). the cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to additional anesthesia in another surgical procedure. according to the local supplier, the affected products were distributed in hong kong and have been located and returned. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

Confidence Spinal Cement System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Confidence Spinal Cement System
  • Manufacturer
    DePuy

Manufacturer

DePuy