Events

Alerta De Seguridad para RENEGADE MICROCATETER - Registered in Anvisa under the number 10341350227. Models / Lots - see attached relation.

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
    984
  • 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
    The product listing included in this "Voluntary Customer Gather Notification" provides a list of all UPN codes and affected lots, as well as their catalog numbers and expiration date range for those affected products. Based on our records, the attached Verification and Traceability Response Form contains product information for all affected products purchased by you. When inquiring whether you have affected product in your stock, please refer to your Verification and Traceability Response Form and the affected products listed in this Attachment Notice. Anvisa is following this action.
  • Causa
    It has been reported that the bag sealing (top sealing) may be broken. if a compromised sealing is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, septic endocartitis, organ failure, and death.
  • 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

RENEGADE MICROCATETER - Registered in Anvisa under the number 10341350227. Models / Lots - see at...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA