Events

- Trade name: GYNECARE THERMACHOICE ™ III Thermal Balloon Ablation Silicone Catheter. - ANVISA registry number: 10132590446. - Class of risk: II - Medium Risk. - Model (s) affected; and Lot (s) / Serial Number (s) Affected: Model TC033. Lots marketed in Brazil: GLMG09; GPMG01; HBMG05; HBMG09; HDMG01; HEMG01; HGMG02; HLMG06; HMMG01; HPMG03 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1781
  • 날짜
    2015-12-28
  • 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
    Return of all products code TC033 within the validity period for the company.
  • 원인
    Stability data does not prove the shelf life of two years as indicated on the product label. thus, potential leakage in the y-connection may lead to loss of pressure during a therapy cycle, which may result in suspected uterine perforation by the surgeon requiring additional procedure to exclude perforation. this will also result in ineffective therapy or immediate termination of the procedure requiring repeat procedure in the future. in addition, the heated fluid has potential for leakage through the y-mount out of the catheter handle and can cause damage to the operator. however such leakage is small and slow without any significant damage to the operator.
  • 조치
    a) Classification of the risk: Class III b) Classification of the field action: Recall whose final destination of the product is destruction c) Field action code: 15000175 d) recommendations to users and patients: Return of all products code TC033 within of the period of validity for the company.

Device

- Trade name: GYNECARE THERMACHOICE ™ III Thermal Balloon Ablation Silicone Catheter. - ANVISA re...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.