Alerta De Seguridad para Geon Digital Thermometer.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Geon Corporation.

¿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
    719
  • Fecha
    2003-07-01
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Several incidents were reported to infarmed due to failure of the performance of the aforementioned device, namely the presentation of incorrect readings of body temperature (for example, a reading of 37ºc when the actual temperature would be around 40ºc). consequently, the manufacturer of that device, geon corporation, was contacted to investigate the situation. the conclusions of the report submitted were contradictory since, in the same case, the problem was attributed in turn to a defect in the assembly of the device during manufacture and poor handling when it was transported by air to portugal (the manufacturer is headquartered in taiwan, roc).
  • Acción
    In view of the above, and considering INFARMED that the manufacturer would not be able at this stage to ensure the correct functioning of these devices and in order to protect the health of potential users of them, it was decided to suspend the commercialization of digital thermometers GEON in the national territory of Portugal.

Device

Manufacturer

  • Source
    ANVSANVISA