Events

Rappel de Doro Sterile Disposable Skull Pins

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-01386-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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-01386-1
  • 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
    The manufacturer pro med instruments (pmi) has been made aware of two breakages of the doro sterile disposable skull pins at the tip, which occurred during two surgical procedures. the breakages occurred at the very distal end of the conical part of the skull pin tip. these breakages did not cause any injury to the patient and pmi have not, to date, been made aware of any further adverse events.In a worst case scenario, this issue could lead to slippage which may require remedial action, loosening of the positioning and a delay in surgical procedure or the tip remaining in the skull, which could lead to subsequent complications such as wound healing.
  • Action
    Life Healthcare is requesting customers: 1. Review the Sponsor supplied Customer letter and ensure all users of the device are informed of this recall. If you have transferred the affected items to third parties, forward a copy of the Customer Letter to them; 2. Check your stock for affected Doro Pins Ref: PMI-3006-00 Lot 1704; 3. If you have affected items quarantine them immediately and complete the relevant section in the supplied form; 4. Check any records where the affected lot numbers have been used prior to this notice for discrepancies in the skull pins. If the tips have been noted as not being intact ensure that any remaining pieces are removed from the patient; and 5. Please complete the supplied reply form and return by email to regulatory@lifehealthcare.com.au

Device

Doro Sterile Disposable Skull Pins

Manufacturer

Life Healthcare Pty Ltd