Events

SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 10237580042. Batch: BE30H / 14D01. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd. 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
    1516
  • 날짜
    2014-12-17
  • 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
    At the moment, no technical complaint regarding this model / batch has been registered that could offer any risk to its users. This was a field action triggered based on the information received from COVISA (SP), published in the DOC of 11/27/2014 - page 81. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action proving the destination of non-compliant products.
  • 원인
    Identified the presence of a foreign body (hair) attached to the sealing of the packaging of this needle, resulting from unsatisfactory aspect analysis.
  • 조치
    The company that holds the register will collect the needles. The company advises customers to immediately discontinue the use of the product from the batch mentioned, segregating them and identifying them so that they are not inadvertently used. They will be collected and destroyed. (LETTER TO THE CUSTOMER IN ANNEX)

Device

SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 1023758...

Manufacturer

LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd.
  • Source
    ANVSANVISA