Events

Trade name: VIVANOMED ABDOMINAL KIT Technical name: HEALING Registration number ANVISA: 80170310073 Hazard class: III Model affected: VIVANOMED ABDOMINAL KIT; VIVANOMED ABDOMINAL; VIVANOMED FOAM; HYDROFILM; VIVANOTEC PORT; PLASTIC TRAY Serial numbers affected: REF 409720 lots: 500228119; 500443116; 600216115; 600102111. REF 409721 lots: 400207115; 400316114; 500130115; 500238118. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Bace comércio Internacional ltda.; Paul Hartmann AG 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
    2232
  • 날짜
    2017-03-17
  • 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 recall is occurring voluntarily by the manufacturer of the product. Do not use the product, segregate it and contact registration holder (Bace Comercio Internacional ltda) by telephone (11 3168-0226) or via email (recall@bace.com.br) to schedule a return and exchange of the product.
  • 원인
    Vivano® med abdominal kits are sets of dressings for the treatment of negative pressure wounds in conjunction with a vivano® tec negative pressure therapy system. these kits include in addition to the hydrophobic pu (polyurethane) foam dressing, a protective layer of pe (polyethylene) organ. the organ protection layer is a round micro perforated polyethylene film (ø 65 cm) with 6 welded application pockets, designed to facilitate the introduction of this layer of organ protection between the abdominal wall and internal organs. a deviation in the manufacturing process of the above-mentioned organ protection layer has been identified in our internal routine controls. this can lead to reduced stability of the solder joints, which connect the application pockets to the protective layer of pe organs. high mechanical load can lead to the risk of one of the pockets of the applicator detaching.
  • 조치
    Field Action Code BACE01 triggered under the responsibility of the company BACE COMÉRCIO INTERNACIONAL LTDA. Company will collect.

Device

Trade name: VIVANOMED ABDOMINAL KIT Technical name: HEALING Registration number ANVISA: 801703100...

Manufacturer

Bace comércio Internacional ltda.; Paul Hartmann AG
  • Source
    ANVSANVISA