Events

C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Atrium Australia - Pacific Rim Pty Limited 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-2013-RN-00751-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00751-1
  • 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
    Atrium medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. this becomes evident if:- it becomes difficult to peel the mesh from the handling sleeve, or- the yellow coating material separating the mesh is retained on the clear plastic liner.
  • 조치
    Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.

Device

C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)
  • 모델명 / 제조번호(시리얼번호)
    C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)All lot numbers 10405513 and higherC-QurMultiple Catalogue Numbers affected ARTG Number: 163310C-Qur TacShieldCatalogue Numbers: 31610, 31611, 31612, 31626, 31628, 31633, 31636, 31637, 31638, 31644ARTG Number: 182852C-Qur V-PatchCatalogue Numbers: 31200, 31201, 31202ARTG Number: 174772
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA