Events

Alerte De Sécurité sur Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - Hazard Class: II - MEDICAL RISK - Technical Name: Wire Guide - Affected Models: LW0037; LW0057; LW0077; LW0107; LW0137 - Affected lots: SEE List of affected lots and distribution map (IN ANNEX)

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 Politec Importação e Comércio Ltda.; Bard Peripheral Vascular, Inc..

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
    1420
  • Date
    2014-09-09
  • 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 the company Politec Importação e Comércio Ltda., "It is advisable to closely monitor patients who are known to have been treated using these affected location wires and are still at risk of developing infectious complications. responsible doctor. "
  • Cause
    The bard dualok seal injury wire may inadvertently penetrate / puncture / cut off its original packaging, thus breaking its sterility barrier and bringing the product into contact with the outside of the packaging. the problem described may increase the risk of injury, including complications associated with localized or systemic infections, which may require medical intervention to prevent serious injury.
  • Action
    Company will make the collection and return it to the manufacturer, located in the United States. Code 170/2014.

Device

Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - H...

Manufacturer

Politec Importação e Comércio Ltda.; Bard Peripheral Vascular, Inc.
  • Source
    ANVSANVISA