Events

Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203, 805704, 806405, 806605, 807008, 807205, 807905, 728206, 731007, 731704, 731809, 807108, 731901 , 803510, 803602, 803602, 805603, 730903, 728107,728212, 730406, 730505, 731101, 731201, 731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507, 806602, 807902, 808004, 808501, 808602 , 731004, 731803, 805701. 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
    922
  • 날짜
    2008-06-06
  • 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
    ATTENTION: NO PRODUCT IS BEING REMOVED FROM THE MARKET, SO IT IS NOT NECESSARY TO RETURN ANY PRODUCT TO BOSTON SCIENTIFIC OF BRAZIL LTDA. The batches affected are also described in the document available at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_922_lotes.pdf. #### Update (09/03/2009): The holder of the product registration informed (on 10/20/2008) the UTVIG / Anvisa that finalized this action.
  • 원인
    Boston scientific has identified that the 48 lots listed above may not display the instructions for use inside their packaging. this fact may lead to a delay in the surgical procedure, which may result in risk to the patient, since the user will need to look for the use instructions in the other product box. so far, boston scientific has not received any complaint claiming the absence of the instructions for use. boston scientific has sent the following letter warning about the problem: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/ alert_922_carta.Pdf.
  • 조치
    1. IMMEDIATELY INSPECT ALL PRODUCTS MENTIONED IN THIS NOTIFICATION: - Immediately identify all batches affected by this action in your inventory (and also from the Rooms of Special Procedures, Interventional Radiology, Operating Room, Hemodynamics, Central Service, Shipment, Receipt or any another location). - Segregate these products and verify the presence of the Instructions for Use on the packaging. - If you find units that do not have Instructions for Use, quarantine them until Boston Scientific provides them with a replacement. 2. COMPLETE AND RETURN THE VERIFICATION / TRACEABILITY FORM: - Complete the Verification / Traceability Form (even if you do not have any affected units in your inventory), following the instructions on the form itself at http://www.anvisa.com Return to the Verification / Traceability Form for: RENATA BRANDÃO Fax: (11) 5502 - 8510.

Device

Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 73190...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA