Events

Alerta De Seguridad para QUICKDRAW VENOUS CANE. Anvisa Registry n ° 80219050114. Models: QD22 and QD25. Lots under risk: 59091652, 59094887, 59222657, 59233637 and 59246684 (model QD22); 59085169, 59097289, 59352608 and 59437699 (model QD25).

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 Comércio de Produtos Médico-Cirúrgicos Ltda.; Edwards Lifescience LLC.

¿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
    1315
  • Fecha
    2013-10-22
  • 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
    According to Edwards, the risks associated with specific product removal techniques are as follows: (1) The presence of scar tissue at the incision site can create resistance and increase the force required for removal of the cannula; (2) When the percutaneous technique is used, separation of the cannula may occur during removal if too much compression force is applied at the incision site (i.e. additional to the felt resistance if scar tissue is present).
  • Causa
    Risks associated with product-specific removal techniques quickdraw venous cannula.
  • Acción
    Collection of products at risk. Identify the products in your inventory, identify and segregate them to avoid inadvertent use, and contact Edwards for product return.

Device

QUICKDRAW VENOUS CANE. Anvisa Registry n ° 80219050114. Models: QD22 and QD25. Lots under risk: 5...

Manufacturer

Edwards Lifesciences Comércio de Produtos Médico-Cirúrgicos Ltda.; Edwards Lifescience LLC