Events

Alerte De Sécurité sur Temporary Vein Vein Filter TEMPOFILTER II. Regista Anvisa n. Affected lots: all lots, as of January 1, 2006.

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 LABORATÓRIOS BBRAUN SA..

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
    1056
  • Date
    2011-04-26
  • 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
    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. ####
  • Cause
    Possibility of breaking the stem of the implantable product.
  • Action
    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.