Events

Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix Anterior 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Coloplast 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-2015-RN-00748-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-09-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00748-1
  • 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 tga carried out a clinical review of urogynaecological surgical mesh implants and found that, while there may be a benefit in certain patients there is little evidence to support the overall effectiveness of these surgical meshes as a class of products.The findings from the review have highlighted the importance of:- appropriate patient selection;- surgeon experience; and- the need for fully informed patient consent.Following the tga's review coloplast pty ltd has made significant and substantive updates to the instructions for use (ifu) for the referenced products. additional contraindications, warnings, and precautions have been added to present the most comprehensive and up to date information available.
  • 조치
    Coloplast is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for their range of urogynaecological meshes.. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 12/08/2016.

Device

Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRest...
  • 모델명 / 제조번호(시리얼번호)
    Coloplast urogynaecological surgical meshAris KitARTG Number: 157074Altis SystemARTG Number: 190173Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix AnteriorARTG Number: 190172
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd