Events

Alerta De Seguridad para CONTOUR MICROPARTICLES OF PVA FOR EMBOLIZATION - Registered in Anvisa under the number 10341350316. Lots - Attached List.

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
    983
  • Fecha
    2009-09-22
  • 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
    Attached to this notification is a complete listing of all product codes within the scope of this Voluntary Collection. The company is aware that some customers can often remove the product from their carton (secondary packaging) and store it on the stock shelves only in their primary packaging (pouch). If this is a practice in your unit, it is very important that you use the attached product table very carefully, and consider both the UPN code on the primary packaging (pouch) and the secondary packaging (box) when looking for the affected product / product of this voluntary recall, since the UPN numbers on the internal and external labels are different. The product information listed on your Verification and Traceability Response Form (attached in this alert) provides only the UPN codes of the secondary packaging (carton). Anvisa is following this action.
  • Causa
    The company reports that there may be a possibility of compromising the sterile barrier in some packaging. all affected products are packed in a bottle and subsequently in a pouch. the company concluded that the sterile pouch barrier containing the bottle may be ruptured. disruption of sterilization can lead to contamination, which may pose a risk of adverse effects to the patient's health, including, in more extreme cases, septicemia.
  • Acción
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them in a safe place. (3) Complete and return the account verification and traceability response form to Boston Scientific do Brasil Ltda. - A / C Caroline Yin - Fax: (011) 5502-8510; (4) Pack, identify the box with affected products and request collection by calling (011) 5502-8583.

Device

CONTOUR MICROPARTICLES OF PVA FOR EMBOLIZATION - Registered in Anvisa under the number 1034135031...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA