Events

Alerte De Sécurité sur Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203, 805704, 806405, 806605, 807008, 807205, 807905, 728206, 731007, 731704, 731809, 807108, 731901 , 803510, 803602, 803602, 805603, 730903, 728107,728212, 730406, 730505, 731101, 731201, 731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507, 806602, 807902, 808004, 808501, 808602 , 731004, 731803, 805701.

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 Boston Scientific do Brasil Ltda..

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
    922
  • Date
    2008-06-06
  • 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
    ATTENTION: NO PRODUCT IS BEING REMOVED FROM THE MARKET, SO IT IS NOT NECESSARY TO RETURN ANY PRODUCT TO BOSTON SCIENTIFIC OF BRAZIL LTDA. The batches affected are also described in the document available at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_922_lotes.pdf. #### Update (09/03/2009): The holder of the product registration informed (on 10/20/2008) the UTVIG / Anvisa that finalized this action.
  • Cause
    Boston scientific has identified that the 48 lots listed above may not display the instructions for use inside their packaging. this fact may lead to a delay in the surgical procedure, which may result in risk to the patient, since the user will need to look for the use instructions in the other product box. so far, boston scientific has not received any complaint claiming the absence of the instructions for use. boston scientific has sent the following letter warning about the problem: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/ alert_922_carta.Pdf.
  • Action
    1. IMMEDIATELY INSPECT ALL PRODUCTS MENTIONED IN THIS NOTIFICATION: - Immediately identify all batches affected by this action in your inventory (and also from the Rooms of Special Procedures, Interventional Radiology, Operating Room, Hemodynamics, Central Service, Shipment, Receipt or any another location). - Segregate these products and verify the presence of the Instructions for Use on the packaging. - If you find units that do not have Instructions for Use, quarantine them until Boston Scientific provides them with a replacement. 2. COMPLETE AND RETURN THE VERIFICATION / TRACEABILITY FORM: - Complete the Verification / Traceability Form (even if you do not have any affected units in your inventory), following the instructions on the form itself at http://www.anvisa.com Return to the Verification / Traceability Form for: RENATA BRANDÃO Fax: (11) 5502 - 8510.

Device

Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 73190...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA