Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - Hazard Class: II - MEDICAL RISK - Technical Name: Wire Guide - Affected Models: LW0037; LW0057; LW0077; LW0107; LW0137 - Affected lots: SEE List of affected lots and distribution map (IN ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Politec Importação e Comércio Ltda.; Bard Peripheral 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
    1420
  • 날짜
    2014-09-09
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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 the company Politec Importação e Comércio Ltda., "It is advisable to closely monitor patients who are known to have been treated using these affected location wires and are still at risk of developing infectious complications. responsible doctor. "
  • 원인
    The bard dualok seal injury wire may inadvertently penetrate / puncture / cut off its original packaging, thus breaking its sterility barrier and bringing the product into contact with the outside of the packaging. the problem described may increase the risk of injury, including complications associated with localized or systemic infections, which may require medical intervention to prevent serious injury.
  • 조치
    Company will make the collection and return it to the manufacturer, located in the United States. Code 170/2014.