Events

Alerta De Seguridad para DENSE RETENNOUS DRAINAGE DUCTLE DOUBLE EDWARDS ENTRY. REG ANVISA (80219050031). Affected lots: 58449974, 58448226 and 58440709.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Edwards Research Medical Inc.; Edwards Lifesciences Com. 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
    933
  • Fecha
    2008-07-29
  • 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
    Edwards Lifesciences Ltda has already sent the communication letters to its customers and has verified, so far, that there are 10 units of the affected product in Brazil (7 in the company's own stock and 3 with a single customer), all from the same lot (58449974 ). The letter sent by the company to the clients is available in Annex 1. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    Metallic wire used to strengthen the inner wall of the cannula may loosen, which can result in reduced venous return.
  • Acción
    According to information presented by the holder of the product registration in Brazil, the actions recommended to customers are as follows: (1) Check if there is any affected product in your inventory; (2) If it exists, segregate the product immediately, identifying it to avoid its use; (3) Return all affected products not used to Edwards Lifesciences CPMC Ltda (see address in the "Manufacturer's Description" field); (4) Complete the recall confirmation form sent by the company, even if you do not have the product affected by the recall in stock, and fax it to (11) 5557-5237.

Device

DENSE RETENNOUS DRAINAGE DUCTLE DOUBLE EDWARDS ENTRY. REG ANVISA (80219050031). Affected lots: 58...

Manufacturer

Edwards Research Medical Inc.; Edwards Lifesciences Com. de Produtos Médico-Cirúrgicos Ltda