Events

AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 American Medical Systems 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-2013-RN-00230-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00230-1
  • 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
    Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in australia were released despite not fully meeting the manufacturer's product release criteria.
  • 조치
    AMS is advising that the risk of prophylactic removal of implanted control pumps outweighs any benefit. Physicians are requested to review the information in the Hazard Alert and use normal clinical practice to determine necessary actions. for more details, please see http://www.tga.gov.au/safety/alerts-device-ams800-controlpump-130326.htm .

Device

AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA