Events

Retiro De Equipo (Recall) de Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConvaTec 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-2015-RN-01155-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-27
  • 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-01155-1
  • 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
    Convatec have determined that specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. therefore the nebuliser mask will not deliver the expected therapy to the patient.
  • Acción
    The sponsor ConvaTec is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor/distributor. This action has been closed-out on 26/08/2016.

Device

Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int
  • Modelo / Serial
    Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) intProduct Code: 1638-00Uno Multi-angle nebuliser MP T-Piece (50) intProduct Code: 1638-01Uno Aero Mask AD MA Nebuliser 210cm (50) intProduct Code: 1651-21Uno Aero Mask Child Multi-Angle Nebuliser 210cm (1x50) intProduct Code: 1654-21Multiple Lot Numbers affectedARTG Number:160226
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd