Events

Retiro De Equipo (Recall) de Freedom Healthcare Quad Walkers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gainsky Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-01130-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01130-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The sponsor has become aware of a fault where the front right wheel of specific quad walkers has either worked loose, or the wheel has sheared off the frame of the walker. when the wheel shears off, the wheeler becomes unstable and the user may become unsteady on their feet and lose their balance.
  • Acción
    1. Users are to find the information sticker on the walker and look at the batch number stamped on the sticker. Photographs of the location of the sticker to assist customers will be provided with the customer letter. Verify the unit is affected stock. 2. Take the walker to the place of purchase where you will be offered a replacement walker or a refund of your purchase price. 3. A representative will contact distributors to arrange to recover any stock of the defective products held and replace them with sound items. For further information, please see https://www.tga.gov.au/alert/freedom-healthcare-quad-walkers

Device

Freedom Healthcare Quad Walkers
  • Modelo / Serial
    Freedom Healthcare Quad WalkersModel Numbers: BRO209 and BRO199Batch Numbers: FHFHCBR13 and FHFHCBR15Manufactured in June 2016 and October 2016 ARTG Number: 137219
  • Manufacturer
    Gainsky Pty Ltd

Manufacturer

Gainsky Pty Ltd