Events

Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Risk classification IV-Maximum Risk. Lots affected: 172 lots (description of the attached lots, next to the letter to the clients) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Cordis Corporation 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
    1910
  • 날짜
    2016-06-14
  • 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
    Recommendations to users and patients: Check the inventory immediately to confirm if you have any of the affected lot units. Identify and separate the units of the affected lots so as to ensure that the affected product is not used. Check all the places of storage and use.
  • 원인
    Based on recent complaints and subsequent investigation, the company detected that products manufactured between april 27, 2015 and november 22, 2015 are associated with an increase in the frequency of incidents of difficulty of placement and in some cases separation of the rod of the external limb resulting in the impossibility of implanting the stent or in the possibility of partial placement of the stent. considering the risk analysis of the product, the potential impact of the impossibility of implanting the stent or the possibility of partially implanting the stent include a delay during the procedure while a replacement device is prepared; vessel injuries requiring unplanned percutaneous or surgical intervention to prevent injury or permanent disability; or in more severe cases, transient ischemic attack or stroke.
  • 조치
    Action code 16000079. Letter to customers //// Collection.

Device

Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Ris...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Cordis Corporation