Events

Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling 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-2017-RN-01542-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-12-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01542-1
  • 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
    On november 28, 2017, the therapeutic goods administration (tga) notified coloplast of tga’s decision to remove transvaginal mesh products used to treat pelvic organ prolapse (pop), and single incision mini-slings from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.Following this direction from tga, coloplast is recalling all restorelle directfix anterior, restorelle directfix posterior, and altis single incision sling products from the australian market.No other coloplast devices are affected by this recall.
  • 조치
    Coloplast is advising hospitals to quarantine any affected product for return to Coloplast. Instructions for product return are provided on the Customer Letter issued to affected customers.

Device

Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling
  • 모델명 / 제조번호(시리얼번호)
    Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision SlingRestorelle DirectFix AnteriorModel/Catalogue Number: 501450SKU Number: 5014501022ARTG 190172Restorelle DirectFix PosteriorModel/Catalogue Number: 501460SKU Number: 5014601022ARTG 190172Altis Single Incision Sling SystemModel/Catalogue Number: 519650SKU Number: 5195601022ARTG 190173
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd