Events

Retiro De Equipo (Recall) de KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO Grey

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por K Care 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-2015-RN-00277-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-30
  • 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-2015-RN-00277-1
  • 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
    K care received complaint that the new walking frame has fallen apart while been used by a patient. on examination, 14 walking frames were found to be faulty. k care decided to remove all frames with a white expander connection, as it was apparent they were a different product from the frames that were from earlier deliveries, with a grey expander connector.The material composition of the pintel that connected the horizontal rail to the vertical leg had been changed. the new composition material (white) was too soft and did not retain its integrity when the nut was tightened.
  • Acción
    K Care sales representatives contacted all the customers. All the affected products are corrected. K Care sales representatives also checked the potentially affected products of the model supplied and confirmed that the products are not affected.

Device

KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My...
  • Modelo / Serial
    KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO GreyModel Numbers:KA351 & KA351SGARTG Number: 209821
  • Manufacturer
    K Care Pty Ltd

Manufacturer

K Care Pty Ltd
  • Source
    DHTGA