Events

Safety Alert for - 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1781
  • Date
    2015-12-28
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Return of all products code TC033 within the validity period for the company.
  • Reason
    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.
  • Action
    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.