Events

Alerta De Seguridad para Trade name: FLEXIBLE STRAWBERRY Ø 8.0 X 360 MM Technical name: ANVISA registration number: 80145901628 Hazard class: III Affected model: BONE TISSUE CUTTING INSTRUMENT Affected serial numbers: Code: 351.430 || Lot: 5923609 || Quantity: 1 item.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Industria e Comercio de Produtos para Saúde Ltda; Synthes GmbH.

¿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
    2116
  • Fecha
    2016-07-19
  • 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 patient or user using the product may be briefly exposed to potentially cytotoxic material, to consequences that could be the adverse tissue reaction, and delay in surgery.
  • Causa
    The device did not pass the biological safety assessment for cytotoxicity upon exposure to test conditions. the high levels of growth inhibition observed during the test can be attributed to the corrosion of the device at weld points. this could be reproduced during use and reprocessing.
  • Acción
    Field Action Code R2016030 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

Trade name: FLEXIBLE STRAWBERRY Ø 8.0 X 360 MM Technical name: ANVISA registration number: 801459...

Manufacturer

Johnson & Johnson do Brasil Industria e Comercio de Produtos para Saúde Ltda; Synthes GmbH