Alerte De Sécurité sur Absorbable Collagen Sponge

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

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
    2013-06-13
  • Date de publication de l'événement
    2013-06-13
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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: integra lifesciences absorbable collagen sponge medical device manufacturer, integra lifesciences corporation, has issued a medical device safety alert concerning certain lots of the absorbable collagen sponge (acs) which is a component of the infuse bone graft kit [model no.: 7510050, 7510100, 7510200, 7510800]. the manufacturer had identified through an internal quality assurance review of processes that may have deviated from a production process during the manufacturer of specific lots of products. the products lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation, they may have been released with higher level of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. the manufacturer is not aware of any reports of patient injuries or other adverse events in connection with these product lots. the manufacturer recommends affected healthcare professionals to monitor their patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol. the manufacturer also advises all affected users to discontinue use of the captioned products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 jun 2013.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Integra LifeSciences Absorbable Collagen Sponge
  • Manufacturer

Manufacturer