Events

HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004); CLIPS DE TITÂNIO HORIZON (Reg. 80117580007). Products Affected: Lots produced until end of July 2008. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Weck Closures Systems 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
    943
  • 날짜
    2008-10-08
  • 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
    The holder of the registration of the products in Brazil (Brasil Import Ltda.) Received from the manufacturer an alert reporting quality control failure in relation to some product packaging - the process of placing the staple cartridge in the blister caused damage in some packages, resulting in holes that compromise the sterility of the products. As a result of the problem, the registry holder, together with the authorized distributor of the product (TC Técnica Cirúrgica Ltda), decided to collect all lots of the products under risk marketed in Brazil. Brasil Import Ltda informed the Tecnovigilance Unit that it has already started sending letters of communication to its clients (see Attachment to Customers - http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_943_carta.pdf) .
  • 원인
    Possibility of holes in the packaging of the staples, which can compromise the sterility of the products.
  • 조치
    The company that owns the product registrations in Brazil (Brasil Import Ltda.) Informed the Anvisa Tecnovigilance Unit (UTVIG / ANVISA) that it suspended the sale and is collecting all the batches of the mentioned products from the market (see Product Description field). The actions recommended to users and distributors of the products are as follows: (a) Check your stock and immediately stop the use / distribution of products at risk; (b) Segregate the products at risk, identifying them correctly to avoid inadvertent use; (c) Return the affected products to the distributor TC Técnica Cirúrgica Ltda (Rua Alberto Folloni 1040 - Bairro Ahú - CEP: 80540-000 - Curitiba / PR); (d) The Stock Status Report and Recognition Form for the aforementioned products must be sent to TC Técnica Cirúrgica Ltda through FAX (41) 3302-2133, even if the affected product is not found in stock.

Device

HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004);...

Manufacturer

Weck Closures Systems
  • Source
    ANVSANVISA