Events

Alerta De Seguridad para BIOSSIMETRIC - Record 80434370001 - All Batches in all presentations.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MTC MEDICAL COMÉRCIO INDÚSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS.

¿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
    1211
  • Fecha
    2012-12-05
  • 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 is an injectable implant, the base of polymethylmethacrylate (PMMA), used in repairing plastics and manufactured by the company MTC Medical Trade Industry Import and Export of Biomedical Products. Anvisa found that the company was not manufacturing the product as recorded. In investigative inspection, the Agency detected the nonobservance of items foreseen in RDC 59/2000, which entails a high degree of risk to the users' health. The company must collect all available lots on the market.
  • Causa
    Company does not manufacture the product according to the registration granted by anvisa. http://portal.Anvisa.Gov.Br/wps/wcm/connect/23caf2804db60436ad4fbdd6059e5711/re5139mtc.Pdf?mod=ajperes.
  • Acción
    Immediate disruption of use, stock segregation, product recall on the market.

Device

BIOSSIMETRIC - Record 80434370001 - All Batches in all presentations.

Manufacturer

MTC MEDICAL COMÉRCIO INDÚSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS
  • Source
    ANVSANVISA