Events

Alerta De Seguridad para Trade name: Kage Cervical //. Technical Name: Disk replacement interbody spacing device //. ANVISA registration number: 80240590034 //. Risk class: III - High Risk //. Model affected: KAG04 //. Batch number affected: 467 / 025-1

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ortech Medical Com.; Kasios.

¿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
    2034
  • Fecha
    2016-11-22
  • 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
    Segregate the product immediately and do not use the affected lot.
  • Causa
    During the sterilization validation procedure carried out by the sterilizing company, a risk was identified in the sterilization process. such non-compliance leads to the risk of an adverse event, such as infection after product implantation.
  • Acción
    Field Action Code 002/2016 / B triggered under the responsibility of Ortech Medical Com. Imp. Exp. Ltda. Company will collect for later return to the foreign manufacturer.

Device

Trade name: Kage Cervical //. Technical Name: Disk replacement interbody spacing device //. ANVIS...

Manufacturer

Ortech Medical Com.; Kasios
  • Source
    ANVSANVISA