INSTRUMENTAL FOR HYGIENE SURGERY. Registro ANVISA n ° 80005430185 .. Units affected: see Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Mensagem_de_Alerta_.pdf?MOD=AJPERES. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 STRYKER 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
    1189
  • 날짜
    2012-10-03
  • 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, there is a potential danger associated with this product field action: presence of a metal fragment in the internal screwed part of the conical body. There are two predictable sequences of events associated with the presence of a metal fragment: (a) In the first, the fragment falls into the wound and is observed by the surgeon. The dangerous situation is the extra time to remove the fragment. The associated potential risk is an extended surgery time of less than 30 minutes; (b) In the second predictable sequence of events, the fragment falls into the wound and is not observed by the surgeon. The dangerous situation is the fragment being implanted in the patient. The associated potential risk is a localized biological response. As a risk mitigation measure, a field action of the product is being conducted to investigate the presence of the metal fragment. For instructions on completing the Product Field Action Science Form and other information, consult the Company Alert Message at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Alerta_Message_.pdf? MOD = AJPERES #### Update (13/11/2012): According to Sryker, all affected customers have already been informed and no nonconformities have been detected in the products under risk in Brazil. The field action was closed by the company on 11/09/2012.
  • 원인
    Possibility of presence of a metal fragment in the last screwed accessory of the studies of the restoration of modular conical body.
  • 조치
    Users are advised to: 1. Instantly locate the objects in this notification; 2. Inspect the devices according to the instructions provided by the manufacturer in the Product Correction Notice attached to this action; 3. Withdraw from operation all devices that fail the inspection, with return delivery to Stryker; 4. Complete the attached Customer Response Form indicating the inspection results for all of the devices in this notification.

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    ANVSANVISA