Events

Rappel de Brennen Skin Graft Mesher - 4.5 and 6.5 inch

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Molnlycke Health Care Pty Ltd.

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-2017-RN-00536-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-01
  • 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-2017-RN-00536-1
  • 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
    Resulting from a post-market internal investigation, mölnlycke has identified a potential safety issue regarding the current sterilisation validation for the brennen skin graft mesher. with the current sterilisation instructions contained in the instructions for use (ifu), the sterility of the mesher cannot be guaranteed following a sterilisation cycle carried out according to those instructions. given the sterility of the brennen skin graft mesher cannot be guaranteed there is a risk for possible contamination, which may lead to infection. mölnlycke confirms that no product, patient or user complaints have been reported to date for products in australia regarding this issue.
  • Action
    Mölnlycke is advising users to immediately stop using the Brennen Skin Graft Mesher and apply the tag (i.e. label) provided by Mölnlycke to the device, or otherwise remove the device from service using applicable labelling and/or quarantine measures under the respective in house quality management system. The tag supplied states that the device is out of service and should not be used. Once the new sterilisation parameters have been confirmed by the manufacturer, through further validation testing during May, Mölnlycke will send users the updated IFU defining the new Sterilisation Procedure. This is estimated to occur in June 2017.

Device

Brennen Skin Graft Mesher - 4.5 and 6.5 inch
  • Modèle / numéro de série
    Brennen Skin Graft Mesher - 4.5 and 6.5 inchProduct Codes: 131500, 131501, 131502, 131503, 131504, 131506, 131600, 131601, 131602, 131603, 131604All Lot NumbersARTG Number: 196830
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd