Events

Alerte De Sécurité sur Embol-X Glide - Arterial Embolic Protection System. Registro Anvisa n ° 80219050099. All lots of the product are under risk.

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 EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS 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
    1311
  • Date
    2013-10-18
  • 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
    Through an evaluation of post-marketing surveillance data the manufacturer identified a potential risk for cardiopulmonary health in patients undergoing bypass surgery when using the Embol-X Glide Protection System. As a result, Edwards Lifesciences is collecting all batches of the Embol-X Glide product that have not expired. See the Urgent Security Notice issued by Edwards at: http://portal.anvisa.gov.br/wps/wcm/connect/35b51a80418119e795b7f722d1e56fc9/EMBOLX_CARTA_CLIENTE.pdf?MOD=AJPERES
  • Cause
    Potential risk for cardiopulmonary health in patients undergoing by-pass surgery, when using the embol-x glide protection system.
  • Action
    Edwards Lifesciences is collecting all batches of the Embol-X Glide product that have not expired. Identify in your inventory the product under risk, identify it properly as inappropriate for use and segregate it to avoid inadvertent use (quarantine). Complete and send the information of the form provided by the company (see form in the Urgent Security Notice issued by the company).

Device

Embol-X Glide - Arterial Embolic Protection System. Registro Anvisa n ° 80219050099. All lots of ...

Manufacturer

EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.