Events

Alerta De Seguridad para Biatain Alginate, lot 52847

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Coloplast do Brasil Ltda.; Coloplast A/S.

¿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
    1411
  • Fecha
    2014-07-28
  • 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 company Coloplast do Brasil Ltda will collect the product. For more information, please contact the company by phone (21) 3212-4259 and email brpr@coloplast.com
  • Causa
    The company importing the product informed that there was an error in the import process and the manufacturer sent the biatain alginato product to brazil in place of the seasorb soft product. the nota fiscal indicates that the product is seasorb soft, but in reality the physical product is biatain alginate. the biatain alginate product is not registered in brazil.
  • Acción
    The company informs that the product should not be used. It directs that the inventory is checked and, if the product is available, that it be segregated. Please check the attachment - Coloplast Customer Letter

Device

Biatain Alginate, lot 52847

Manufacturer

Coloplast do Brasil Ltda.; Coloplast A/S