Events

Rappel de SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard Australia 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-2016-RN-01314-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-06
  • 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-2016-RN-01314-1
  • 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
    It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect instruction for use (ifu) containing a table in the description section that misidentifies the wireform and material (titanium and stainless steel). all other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a senomark ultracor mri 14 gauge tissue marker of the wrong material in a patient with known hypersensitivity to titanium.
  • Action
    Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. This action has been closed-out on 17/05/2017.

Device

SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast bio...
  • Modèle / numéro de série
    SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)Product code: SMUCMRI14GTLot number: VT15M0543ARTG number: 160027
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd