Events

CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See attachment at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/995_lista_produtos.pdf 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific 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
    995
  • 날짜
    2009-11-03
  • 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
    Any distribution or use of any remaining product affected by this Voluntary Settlement must stop immediately. This Voluntary Collection does not include any product other than those of the affected lots listed in the Annex. Regulatory authorities around the world that are affected by this Voluntary Removal for Removal are being notified as required. Please carefully read the pickup instructions included with this Voluntary Referral Notification to the Customer. Your local Sales Representative can answer any questions you may have regarding this Volunteer Recruitment. More attachments at: http://www.anvisa.gov.br/tecnovigilancia/alertas/index.htm
  • 원인
    Boston scientific has concluded that the seal on the sterile packaging of the affected products may be compromised. it has been reported that the sealing of the outer pouch may be ruptured. if a compromised seal is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, sepsis, endocarditis, organ failure, and death.
  • 조치
    The necessary actions are as follows: (1) Check in your stock if you have affected products; (2) Segregate affected products by visually identifying them with a label; (3) Contact the product registration holder (Boston Scientific of Brazil) or an authorized distributor for the return of the material. The use of affected products in stock must cease immediately.

Device

CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See att...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA