Events

Retiro De Equipo (Recall) de Allen Medical Bow Frame

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

¿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-01421-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-24
  • 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-01421-1
  • 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
    Allen medical has become aware of a potential risk, which could result in critical harm to the patient if the base of the bow frame were to crack during use. since the introduction of this product in march 2017, one complaint with no injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • Acción
    Allen Medical is advising users to remove affected bow frames from use, until the units are corrected.

Device

Allen Medical Bow Frame

Manufacturer

Denyers Pty Ltd T/a Denyers International