Events

Alerta De Seguridad para Embol-X Glide - Arterial Embolic Protection System. Registro Anvisa n ° 80219050099. All lots of the product are under risk.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS 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
    1311
  • Fecha
    2013-10-18
  • 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
    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
  • Causa
    Potential risk for cardiopulmonary health in patients undergoing by-pass surgery, when using the embol-x glide protection system.
  • Acción
    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.