Events

Retiro De Equipo (Recall) de REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes)

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

¿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-2016-RN-00852-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-01
  • 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-2016-RN-00852-1
  • 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
    Rex bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the rex. the patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. the injuries may have been exacerbated by the use of ankle foot orthoses (afo) which restricted the users’s range of motion greater than required by rex.The heel stop must be correctly aligned with the measurement on the footplate corresponding to the user’s ankle to hind-foot measurement. once adjusted, the heel stop must be secured by tightening the locking nut. failure to do this may cause the user’s leg to move out of alignment, which may result in serious injury.
  • Acción
    Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017.

Device

REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-...
  • Modelo / Serial
    REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) All devices affectedARTG Numbers: 237572, 271519
  • Manufacturer
    Rex Bionics Australia Pty

Manufacturer

Rex Bionics Australia Pty
  • Source
    DHTGA