Events

Alerte De Sécurité sur - 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1781
  • Date
    2015-12-28
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Return of all products code TC033 within the validity period for the company.
  • Cause
    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.