Events

Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Risk Affected models: See alert on Anvisa Portal 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S. 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
    2206
  • 날짜
    2017-02-20
  • 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
    - Segregate the product so that it is not used - Do not deploy the affected product
  • 원인
    Suspension of the use of the inmetro compliance seal for the round collection family of products due to the presence of particles detected in a sample collected during the annual maintenance process. ### update: the suspension of certification was revoked on 8/1/2017 "(...) after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, through an extraordinary audit and the tests required by the regulation ..". however, "(...) revocation of the suspension is applicable only to products produced and imported after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, and the holder of the certification must keep the stock of previously produced products locked and under suspicion, (...) ".
  • 조치
    Field Action Code 001/17 triggered under the responsibility of the company EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will make inventory segregation, communication of surgeons and investigation of the event.

Device

Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Ri...

Manufacturer

EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S.
  • Source
    ANVSANVISA