Events

Retiro De Equipo (Recall) de miraDry System (used for the treatment of primary axillary hyperhidrosis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Consulting 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-01234-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-16
  • 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-01234-1
  • 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
    Device consulting has been advised that clinics may use substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly containing and cooling the skin and cause minor burns and blisters. whilst there have not been any adverse events reported in australia, device consulting is updating the user manual for the miradry system to include the statement: “do not use lubricants other than the recommended lubricants (k-y jelly or k-y liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
  • Acción
    Device Consulting is providing users with an updated user manual, including additional warnings regarding the use of non-validated solutions. This action has been closed-out on 26/08/2016.

Device

miraDry System (used for the treatment of primary axillary hyperhidrosis)
  • Modelo / Serial
    miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967
  • Manufacturer
    Device Consulting Pty Ltd

Manufacturer

Device Consulting Pty Ltd