Events

BASS PROFILE GASTROSTOMY REPLACEMENT KIT. Model: WIZARD. Anvisa Registry: 10178010088. Affected lots: several batches manufactured from 2003 to January 2008 (for details of batches affected, access http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/951_produtosafetados.pdf). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 POLITEC IMPORTAÇÃO E COMÉRCIO 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
    951
  • 날짜
    2009-01-16
  • 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
    According to Politec Ltda, the product manufacturer (Bard Access System Inc.) started collecting the product due to constant complaints about valve breakage. This problem causes leakage of gastric contents and feed solutions, resulting in inconvenience to the user. According to the company, no damage, in addition to slight skin irritation, has been reported with valve breakage. UTVIG / Anvisa is following up on this case.
  • 원인
    The manufacturer of the product (company bard access systems) is collecting the product on the world market due to continuous valve breakdown claims.
  • 조치
    The holder of the registration of the product in Brazil informed the UTVIG / Anvisa that it has already begun sending letters of communication to the distributors / users of the product, as well as the collection of affected lots. According to the company, it is not necessary to remove the already deployed devices. The user of the product should take the following measures: (1) Check for affected products in stock; (2) If affected products are found, immediately cease their use and distribution, segregating them immediately - identify with a label, to avoid inadvertent use; (3) Return the affected products to the registry holder Politec Imp. and Com. Ltda (address in the field Manufacturer's description) or to a distributor of the product; (4) Fill in the Product Collection Form (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/951_carta.pdf) and send it to Politec Ltda, according to the instructions on the form itself.

Device

BASS PROFILE GASTROSTOMY REPLACEMENT KIT. Model: WIZARD. Anvisa Registry: 10178010088. Affected l...

Manufacturer

POLITEC IMPORTAÇÃO E COMÉRCIO LTDA.