Events

Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook Australia 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-00328-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00328-1
  • 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
    Cook medical is instigating a change in the intended use wording of the product instructions for use (ifu). this change is in response to the report of two potential adverse events during use in urological or gynecological procedures. this change will provide clarification of the product's intended use, with the addition of the following statement in the ifu: "this device is not intended for use in urological or gynaecological procedures".
  • 조치
    Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update.

Device

Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft
  • 모델명 / 제조번호(시리얼번호)
    Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue GraftCook Biodesign 1-Layer Tissue Graft Model Numbers: C-SLH-1S-2X3, C-SLH-1S-7X10, SLH-1S-7X10Cook Biodesign 4-Layer Tissue GraftModel Numbers: C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, SLH-4S-2X3, SLH-4S-3.5X5, SLH-4S-4X7, SLH-4S-7X10, SLH-4S-7X20ARTG Number: 153047
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd