Events

LEVEEN NEEDLE ELECTRODE. Anvisa Registry nº 10341350365. Lots Affected: Verify at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_carta.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
    919
  • 날짜
    2008-05-12
  • 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
    The occurrence of an adverse event associated with the cited problem could lead to bleeding and soft tissue trauma due to the fact that the stems were not fully collected. Such an occurrence could lead to medical intervention. The letter of information to the clients and the form sent by Boston are in ANNEXES. Anvisa's Technovigilance Unit is monitoring this case. APPENDICES: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_carta.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_formulario.pdf UPDATE: The company communicated the closing the recall action and sending the products collected to the Boston Scientific Distribution Center located in Quincy / USA.
  • 원인
    Possibility of the leveen needle electrode cannula come out of its correct orientation inside the gauntlet, which can result in no full recoil of its rods.
  • 조치
    Boston Scientific do Brasil Ltda has voluntarily initiated the market withdrawal of all unexpired batches of Agilha LeVenn SuperSlim Electrodes. The company has informed UTVIG that the distribution or use of any remaining product affected by this recall action of medical product must cease immediately. The instructions for health professionals are as follows: (1) Immediately discontinue use and segregate products affected by this recall; (2) Complete the verification / traceability form provided by the company and send the response to Boston Scientific do Brasil (fax 11-5502-8539, A / C Camila Domeneck); and (3) Pack and ship the product to the company, identifying the box with the customer's name (the company address is in the "Manufacturer's description" field of this form).

Device

LEVEEN NEEDLE ELECTRODE. Anvisa Registry nº 10341350365. Lots Affected: Verify at http://www.anvi...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA