Events

Retiro De Equipo (Recall) de Cochlear Soft Tissue Gauge

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Cochlear Bone Anchored Solutions AB.

¿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
    16554
  • Fecha de inicio del evento
    2014-04-17
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Cochlear NZ Limited, C/- KPMG, 18 Viaduct Harbour Ave, Auckland 1010
  • Causa
    Manufacturer informed of a potential quality issue with the product. a health risk assessment was performed and the following potential risks were identified:, 1. metal fragement comes loose and ends up on/ under the patient's skin during surgery casuing an inflammatory response, 2. endotocins lefton instrument after cleaning and sterilisation, 3.Metal fragment/ sharp edge (causing additional scratches to soft tissue during surgery.).
  • Acción
    Product to be destroyed

Device

Cochlear Soft Tissue Gauge

Manufacturer

Cochlear Bone Anchored Solutions AB