Events

Rappel de Versate Monofilament Mesh, 50x50 cm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-2018-RN-00191-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-08
  • 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-2018-RN-00191-1
  • 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
    Medtronic has been made aware of patient reports of abdominal hernia recurrence following hernia repair using versatex monofilament mesh 50 x 50 cm. the risk is highest in patients who have comorbidities. the majority of these patients have been confirmed to have undergone the transversus abdominis muscle release (tar) procedure.
  • Action
    Medtronic is adding the following statement to the Versatex monofilament mesh Instructions for Use so that surgeons are aware of the risks involved in using Versatex monofilament mesh 50x50 cm in TAR procedures: "In case of large abdominal wall defects, use of Versatex monofilament mesh in posterior component separation techniques with transversus abdominis muscle release may lead to a higher risk of hernia recurrence. Versatex monofilament mesh is not recommended for posterior component separation techniques with transversus abdominis muscle release when the mesh is used as a bridging material for the lateral relaxing incisions."

Device

Versate Monofilament Mesh, 50x50 cm
  • Modèle / numéro de série
    Versate Monofilament Mesh, 50x50 cmItem Code: VTX5050MARTG Number: 237409(Medtronic Australasia - Abdominal hernia surgical mesh, synthetic polymer)
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA