Events

COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719 and HA140448; COSEAL 4ml: HA130322, HA130637, HA130721 and HA130919. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BAXTER HOSPITALAR 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
    1409
  • 날짜
    2014-08-11
  • 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
    The product may exhibit reduced effectiveness due to failure to form the hydrogel, or even a hydrogel with mechanical resistance. If the product fails to form hydrogel or the hydrogel formed has an inappropriate (mechanical resistance) during a surgical procedure, the surgeon should use a new product kit or adopt an alternative surgical method. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Message+of+Alerta_VENDA.pdf?MOD=AJPERES #### UPDATED ON 08/18/2017, the documentations of the action field sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • 원인
    The effectiveness of the product may be compromised, given that tests carried out by the company have detected results below the specifications regarding the validity of the product.
  • 조치
    BAXTER HOSPITALAR LTDA is collecting the product (affected batches described above). Do not use the product at risk and identify the hazardous units in your stock, segregate them and contact BAXTER or distributor for return purposes. For details on how to proceed, check additional information in the Alert Message posted by the company: http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Messagem+de+Alerta_VENDA.pdf?MOD=AJPERES

Device

COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719...

Manufacturer

BAXTER HOSPITALAR LTDA.