Events

Rappel de C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Atrium Australia - Pacific Rim Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00751-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00751-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Atrium medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. this becomes evident if:- it becomes difficult to peel the mesh from the handling sleeve, or- the yellow coating material separating the mesh is retained on the clear plastic liner.
  • Action
    Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.

Device

C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)
  • Modèle / numéro de série
    C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)All lot numbers 10405513 and higherC-QurMultiple Catalogue Numbers affected ARTG Number: 163310C-Qur TacShieldCatalogue Numbers: 31610, 31611, 31612, 31626, 31628, 31633, 31636, 31637, 31638, 31644ARTG Number: 182852C-Qur V-PatchCatalogue Numbers: 31200, 31201, 31202ARTG Number: 174772
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA