Events

LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device 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-00405-1
  • 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-00405-1
  • 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
    Advanced medical solutions (ams) extended claims in the instructions for use of liquiband fix8 in may 2015 from "laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or polypropylene / polyester combination hernia mesh to the abdominal wall" to "laparoscopic repair of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and the approximation of peritoneum". a recent technical file audit by the notified body bsi has revealed that more data was required to support these extended claims. until further notice, the fix8 device should only be used as per the original instructions for use, version drm 06 0528 01 (revision 1).
  • 조치
    AMS is providing users with revision 1 of the IFU that is to be used with stock that has been purchased and is currently in stock. Future shipments of the device will be shipped with IFU revision 1 until further notice.

Device

LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device
  • 모델명 / 제조번호(시리얼번호)
    LiquiBand FIX8 Hernia Mesh Adhesive Fixation DeviceProduct Code: FX001ARTG Number: 233374
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd