Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil 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
    922
  • Fecha
    2008-06-06
  • 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
    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.
  • Causa
    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.
  • Acción
    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