Events

Wallstent endoprosthesis with Unistep release system 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BOSTON SCIENTIFIC DO BRASIL LTDA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    864
  • 날짜
    2007-03-27
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    Product registered in Brazil under nº 10341350226
  • 원인
    Boston scientific do brasil ltda reported the voluntary market withdrawal of 136 batches of wallstent tips endoprosthesis with monorail release system - unistep, as it identified "that the products of the lots listed in the appendix (http://www.Anvisa.Gov. can be released with an excessive release force. in response to three product complaints related to this context, boston scientific corporation has initiated an investigation to establish the source of this problem. while this investigation is ongoing, we have determined that products manufactured during the month of october 2006 may be released with a release force greater than normal. since we have defined that release with increased release force may lead to a clinical risk to patients including, inter alia, a risk of prolonging the procedure and potential damage to the vessel, we have decided to initiate voluntary withdrawal from some batches of the product "carotid wallstent". ".
  • 조치
    The Company Boston Scientific do Brasil Ltda. sent a letter to all customers who received the affected products, guiding the discontinuation of use and segregation of the units affected by this voluntary withdrawal; requesting the completion and return of a verification and traceability form.

Device

Wallstent endoprosthesis with Unistep release system

Manufacturer

BOSTON SCIENTIFIC DO BRASIL LTDA
  • Source
    ANVSANVISA