Events

BARDPORT TOTALLY IMPLANTABLE IN PLASTIC AND SILICONE - Registration: 10178010192 - Hazard Class: IV - MAXIMUM RISK 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 POLITEC IMPORTAÇÃO E COMÉRCIO LTDA; BARD ACCESS 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
    1352
  • 날짜
    2014-01-13
  • 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
    If the affected product is implanted in a patient, the manufacturer DOES NOT recommend removing the device. However, the final decision regarding this procedure should be at the discretion of the treating physician. ## UPDATE ON 9/1/2014 - COMPANY COMPLETED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##
  • 원인
    Silicone catheters of particular batches were identified with a size less than 5.3fr than the size of 6.6fr mentioned on the labeling of the product. annex: letter to customers.
  • 조치
    Company is conducting the renegotiation of affected lots. The lots REXC0931 and REXC0736 are under threat in Brazil. ## UPDATE ON 9/1/2014 - COMPANY CONCLUDED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##

Device

BARDPORT TOTALLY IMPLANTABLE IN PLASTIC AND SILICONE - Registration: 10178010192 - Hazard Class: ...

Manufacturer

POLITEC IMPORTAÇÃO E COMÉRCIO LTDA; BARD ACCESS SYSTEMS
  • Source
    ANVSANVISA