Events

Retiro De Equipo (Recall) de Earmoulds in use with children under 36 months

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Starkey Laboratories Australia 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-2018-RN-00474-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-19
  • 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-2018-RN-00474-1
  • 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
    Starkey have been made aware of a single incident in the uk where an unattended child aged 7 months has required treatment to remove an earmould from the larynx. this is the first reported incident of its kind, the likelihood of such event is considered extremely low and on this occasion there was no long-term injury.There have been no reported incidents in australia relating to this issue.
  • Acción
    Starkey is recommending clinicians glue tubing in place for new mould orders manufactured for children up to the age of 36 months. Clinicians are advised to mark orders with "Glue-inTube" when patients meet this criterion.

Device

Earmoulds in use with children under 36 months

Manufacturer

Starkey Laboratories Australia Pty Ltd