Events

Rappel de GYNEMESH PS and TVT DevicesGynemesh PS

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2015-RN-00743-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-02
  • 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-2015-RN-00743-1
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a notification to inform hospitals and surgeons of changes to the instructions for use (ifu) for ethicon gynemesh ps and tvt devices.The changes include additional information on adverse reactions, warnings, precautions and patient selection.
  • Action
    Johnson & Johnson Medical (JJM) is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for Ethicon GYNEMESH PS and TVT Devices. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 22/08/2016.

Device

GYNEMESH PS and TVT DevicesGynemesh PS
  • Modèle / numéro de série
    GYNEMESH PS and TVT DevicesGynemesh PSProduct Codes: GPSL and GPSXL3; TVT DevicesProduct Codes: 810041A, 810041B, 810081, TVTRL, TVTOML ARTG Number: 99193 (TVT) & 165075 (Gynemesh PS)
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd