Events

Alerte De Sécurité sur NeuraGen Nerve Guide and NeuraWrap Nerve Protector

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 LifeScience 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
    2013-04-24
  • Date de publication de l'événement
    2013-04-24
  • 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_20130424a.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: integra neuragen nerve guide and neurawrap nerve protector the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning neuragen nerve guide and neurawrap nerve protector manufactured by integra lifescience corporation. the affected catalogue numbers are png130, png320, png520, png620, nw320, nw520 and the affected lot numbers are 1112378, 1112106, 1112004, 1112030, 1111938, 1112038. through an internal quality assurance review of processes, the manufacturer found that the production process may have deviated during the manufacture of specific lots of product. the product 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 levels of endotoxins than permitted by the specifications for the products. integra is recalling the affected products and advises the clinicians to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00353-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 april 2013.

Device

NeuraGen Nerve Guide and NeuraWrap Nerve Protector
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Integra NeuraGen Nerve Guide and NeuraWrap Nerve Protector
  • Manufacturer
    Integra LifeScience Corporation

Manufacturer

Integra LifeScience Corporation