Events

Alerta De Seguridad para Dialisador CA 210, Lot: A01C04

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar 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
    756
  • Fecha
    2003-11-11
  • 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
    Baxter Hospitalar Ltda reports that: "Previous reports of a similar nature have been associated with the use of dialysers with unmodified cellulose acetate fiber. It is not known to what extent the time and / or storage conditions of the dialysers influence this type of incident. In Brazil we have not received any reports of Red-Eye Syndrome using these dialysers. "///// If your EAS received the batch in question, immediately suspend the use and contact the Manufacturer or your local representative. The Tecnovigilância / ANVISA Unit will be monitoring all actions carried out by the company.
  • Causa
    Reports received from a dialysis clinic in mexico, where 10 patients reported adverse events including conjunctivitis, iritis, malaise, myalgia, and arthralgia combined. these events are related to the syndrome known as "red eye syndrome".
  • Acción
    BRAZIL - 11.11.2003 - Baxter Hospitalar Ltda is initiating the voluntary withdrawal of the A01C04 lot from the dialyzer CA 210 by means of a letter dated 11.11.2003.

Device

Dialisador CA 210, Lot: A01C04

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA