Events

Trade name: GRAFTYS BCP Technical name: ENZYME OSSEO ANVISA registration number: 80517190002 Hazard class: I Target affected: Not applicable 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL 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
    2205
  • 날짜
    2017-02-09
  • 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
    NO PATIENT ALERTING IS NECESSARY. HISTORICALLY WE HAVE NO ADVERSE EFFECT OR ANY KIND OF NOTICE FROM CUSTOMERS OR MEDICAL PROFESSIONALS ABOUT THE FAILURE OF GRAFTYS HBS AND GRAFTYS BCP PRODUCTS USED.
  • 원인
    Due publication of resolution re n ° 325 of february 7, 2017, anvisa determined, as a measure of health interest, in all national territory, article 1, suspension of imports, distribution, marketing and use of graftys hbs and graftys products bcp, imported by the company latim american solutions improtação e exportação ltda, cnpj 09.183.319 / 0001-74, considering the conclusion of the unsatisfactory international inspection report for the graftys sarl manufacturing company of these products, whereas most non-conformities found related directly with the products. in article 2 of this same resolution it has been determined that latin american solutions importação e exportação ltda carries the collection of graftys hbs and graftys bcp products in any national territory. the company will make measures for the pickup to be performed and for the compliance of the suspension.
  • 조치
    Field Action Code 01 2017 triggered under the responsibility of the company LAS - LATTIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will collect.

Device

Trade name: GRAFTYS BCP Technical name: ENZYME OSSEO ANVISA registration number: 80517190002 Haza...

Manufacturer

LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL
  • Source
    ANVSANVISA