Events

URINE SOLIDOR COLLECTOR - Record 10237580033 - Lots Affected 1203B and 1235A. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 LAMEDID COMERCIAL E SERVICOS 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
    1155
  • 날짜
    2012-07-26
  • 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
    Anvisa follows this action. See RESOLUTION - RE Nº 3.172, OF JULY 25, 2012. (Attached). #### UPDATE - 01/11/2012 - CLOSURE - The company sends file 0890363 / 12-3, announcing the closure of the field action. #### UPDATE - 04/16/2013 - The company forwards the certificate of destruction of the products collected through file 0218488 / 13-5. ###
  • 원인
    Anvisa by means of resolution - re nº 3,172, of july 25, 2012, in its article 2, determines the collection of the aforementioned lots, considering tax report 1568.00 / 2012 which establishes that lot 1203b of the collector product adult urine presents a quality deviation from the appearance test because it shows small dark stains along the extension tube and dirt inside the emptying tube and considering the fiscal analysis report 1569.00 / 2012 which establishes that lot 1235a of the product adult filter urine collector shows quality deviation for the appearance assay because it has small dark stains along the extension hose and dirt inside the drain tube.
  • 조치
    Check for this product in stock. Segregate in a safe place for later recall and destruction.

Device

URINE SOLIDOR COLLECTOR - Record 10237580033 - Lots Affected 1203B and 1235A.

Manufacturer

LAMEDID COMERCIAL E SERVICOS LTDA
  • Source
    ANVSANVISA