Events

Alerta De Seguridad para Temporary Vein Vein Filter TEMPOFILTER II. Regista Anvisa n. Affected lots: all lots, as of January 1, 2006.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LABORATÓRIOS BBRAUN SA..

¿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
    1056
  • Fecha
    2011-04-26
  • 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 BBRAUN, the action was taken due to the report of five cases of stem fracture worldwide and there is no report, so far, of adverse events resulting from the problem in question. The migration of the fractured stem would be the main risk for the patient. For more information, consult http://portal.anvisa.gov.br/wps/wcm/connect/11bfe68046a41c38bc30bdc9c474c85c/Carta+Informativa.pdf?MOD=AJPERES.####ATUALIZAÇÃO - 12/13/2011 - The company forwards field action completion report. Of the 41 units sold, 21 were collected and returned to the manufacturer. Corrective measures have been taken provided greater resistance to rupture. ####
  • Causa
    Possibility of breaking the stem of the implantable product.
  • Acción
    The BBRAUN company has already started collecting the product. Health facilities should IMMEDIATELY discontinue use of the product by removing them from the stock and segregating them properly so that they are not inadvertently used. The segregated products should be sent to the distributor, following guidelines of the company BBRAUN. Products already implanted should be removed if the indication of the vena cava filter is no longer justified and, at most, at the end of the tenth week. According to the company, IT IS OF FUNDAMENTAL IMPORTANCE THAT THE FILTER BE REMOVED BEFORE THE END OF THE TWENTY-SECOND WEEK AFTER DEPLOYING THE DEVICE.

Device

Temporary Vein Vein Filter TEMPOFILTER II. Regista Anvisa n. Affected lots: all lots, as of Janua...

Manufacturer

LABORATÓRIOS BBRAUN SA.