Events

Arion silicone breast prosthesis, Record nº 80165560006 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Imact Importação e Comércio Ltda; Laboratoires Arion 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
    1493
  • 날짜
    2014-12-29
  • 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 company must take action to collect the product.
  • 원인
    In the process of maintaining the use of the seal of conformity identification (product certification), during a factory audit, it was verified that the company adopts two methods of sterilization, ethylene oxide and dry heat, only the sterilization method by ethylene oxide is included in the product registration process.
  • 조치
    Publication of Resolution RE No. 4.881, of December 19, 2014, as described below: "Art. 1º To determine, as a measure of sanitary interest, in the whole national territory, the suspension of the importation, distribution, commercialization and implantation of the product MOLECULAR PROSTHETICS OF SILICONE ARION, which includes on the label the information of sterilized by dry heat in registration No. 80165560006, manufactured by Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Article 2. To determine, as a measure of sanitary interest, throughout the national territory, the suspension of the importation, distribution, commercialization and implantation of the product PROSTHETIC MOLECULAR SILICONE ARION sterilized by ethylene oxide, registration 80165560006, manufactured from 28/4 / 2014 by the company Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Art. 3 To determine that the company Imact Importação e Comércio Ltda. promote the collection of existing stock in the market for the products described in arts. 1st and 2nd. "

Device

Arion silicone breast prosthesis, Record nº 80165560006

Manufacturer

Imact Importação e Comércio Ltda; Laboratoires Arion
  • Source
    ANVSANVISA