Events

Alerte De Sécurité sur Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.0-35-150-P-NS-O. Registro Anvisa n °: 10212990249./// On 12/01/2015 - added new lots for the collection: 4350176; 4552616; 4,598534; 4594005; 5,459,289; 4,582479 and 4604577.

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 E. TAMUSSINO & CIA. LTDA; COOK INCORPORATED.

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
    1751
  • Date
    2015-11-21
  • 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
    The recall was initiated by the company because of the potential to cause serious adverse events. Potential adverse events that may occur as a result of division and separation of the catheter tip may include: loss of device function, medical intervention to recover segmented segment and resulting complications from separate tip, such as obstruction of blood flow to the terminal organs.
  • Cause
    The manufacturer, cook medical has received reports of splitting or separation from the catheter tip. potential adverse events that may occur as a result of division and separation of the catheter tip: loss of device function, medical intervention to recover separate segment or resulting complications from separate tip - such as obstruction of blood flow to the terminal organs.
  • Action
    The products are being collected by the registration holder in Brazil (E. Tamussino & Cia Ltda). Segregate the products at risk and inform the company as soon as possible so that the necessary measures are taken. Company code for the field action: T10071-32.

Device

Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.0-35-150-P-NS-O. Regist...

Manufacturer

E. TAMUSSINO & CIA. LTDA; COOK INCORPORATED
  • Source
    ANVSANVISA