Events

Retiro De Equipo (Recall) de O2Vent T (Mandible-repositioning anti-snoring orthosis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Oventus 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-2016-RN-01572-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-02
  • 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-01572-1
  • 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 manufacturer has determined that a correction to the adjuster assembly part of the o2vent t device is necessary and must be returned for rework. the adjuster assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment. the performance of the device and risk to patient safety is affected by the faulty adhesion of the adjuster assembly part.
  • Acción
    Oventus is advising clinicians to inform the patients that are using the affected product and advise them to stop using the device and arrange for it to be returned to Oventus Manufacturing for rework within 10 days. Also, any remaining devices that are currently in their possession should be also be returned for rework. This action has been closed-out on 01/03/2018.

Device

O2Vent T (Mandible-repositioning anti-snoring orthosis)
  • Modelo / Serial
    O2Vent T (Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLDevices manufactured & delivered from 17 Nov 2016ARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd