Events

Alerta De Seguridad para - 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1781
  • Fecha
    2015-12-28
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Return of all products code TC033 within the validity period for the company.
  • Causa
    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.
  • Acción
    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.