Events

Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class: II Affected Model: 1009-00 Serial Numbers Affected: ELVH1102V 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc 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
    2187
  • 날짜
    2017-02-07
  • 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
    For products that were already used in patient, the manufacturer did not request any further action.
  • 원인
    Tecmedic comércio de produtos médicos ltda., on 05/02/2017 received notification of collection of lot elvh1102v of reference 1009-00 of the product valvulotomo hydro longo lemaitre, registered with anvisa under nº 80202919003. this collection was initiated due to to reported problems of failure of the rims to close when the device was triggered. in some cases, this problem was discovered in use and led to damage in the vessel. if the blades are locked in the open position, the device must be removed in the open position. removal of the unassembled device may cause damage to the vein or during use or when the blades pass through the vessel. the manufacturer lemaitre requested the immediate recall of the valvulotomo hydro long lemaitre, model 1009-00, lot elvh1102v and the proper segregation of the parts. after this recall, the manufacturer requested that all units be shipped to lemaitre. for the valvuloto hydro long lemaitre units of the elvh1102v batch used, the manufacturer did not request any further action. tecmedic imported 23 units from the affected lot.
  • 조치
    Field Action Code CWB 02/2017 triggered under the responsibility of the company Tecmedic Comércio de Produtos Médicos Ltda. Company will collect.

Device

Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class...

Manufacturer

Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc
  • Source
    ANVSANVISA