Events

Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, 2637B, 2642B./// Introductory Kit 11F. Lot: 1670C./// Pulsar Pulse Pulsar VDD 870. Series: 207657./// Pacemaker Insignia Model 1198. Series: 102825./// Pacemaker Insignia Model 1298. Series: 151286./// Endocardial Electrode Model 4035. Series: 311672./// Endocardial Electrode Model 4244. Series: 429970, 432590./// Endocardial Electrode Model 4245. Series: 414359, 414402./// Endocardial Electrode Model 4342. Series: 201121./// Fineline Electrode Model 4459. Series: 309880./// Fineline Electrode Model 4473. Series: 318385./// Fineline Electrode Model: 4474. Series: 307118./// Adapter LV-1 IS-1. Lot: 101120, 300661./// Scheduler Model 2920. Series: 30587. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GUIDANT 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
    750
  • 날짜
    2003-10-30
  • 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
    considering the provisions of Article 6 of Law No. 9,782, of January 26, 1999; considering the provisions of Article 6, Item I, and Article 12, paragraph 3, Section III, of Law No. 8,078, of September 11, 1990; considering the Theft Communication of Products for Health of the company GUIDANT DO BRASIL LTDA., File No. 213437 / 03-3; Considering the Boletim de Occurência nº 7844/2003, issued by the 96th Police Station of the Civil Police of the State of São Paulo;
  • 원인
    Stolen health products.
  • 조치
    To determine, as a measure of health interest, the seizure, throughout the national territory, of the products listed below, as they are full batches of stolen health products.

Device

Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, ...

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA