Events

Alerte De Sécurité sur PERMA-HAND Silk Suture

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

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
    2017-01-27
  • Date de publication de l'événement
    2017-01-27
  • 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_20170127.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: ethicon perma-hand silk suture medical device manufacturer, ethicon, has issued a medical device safety alert concerning its perma-hand silk suture (also referred to as mersilk silk suture) [product code: w584; lot number: jcq247]. the manufacturer has initiated a voluntary medical device removal of one lot of ethicon perma-hand silk suture. product from the affected lot was found to have an open sterile packaging seal which could compromise device sterility. at this time, the manufacturer has received no reports of adverse events for this issue. according to the manufacturer’s health hazard evaluation, there is an extremely rare probability of adverse consequences in patients in whom these sutures were used. healthcare practitioners that have treated patients using product from the affected lots should continue to follow those patients in the usual manner. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 january 2017.

Device

PERMA-HAND Silk Suture
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ETHICON PERMA-HAND Silk Suture
  • Manufacturer
    ETHICON

Manufacturer

ETHICON