Events

Doro Sterile Disposable Skull Pins 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01386-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-11-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01386-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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