Events

Retiro De Equipo (Recall) de Hypothermia Caps, Mittens and Slippers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Control Medics 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-00121-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-12
  • 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-00121-1
  • 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
    The manufacturer, southwest technologies are recalling all hypothermia products including caps, mittens and slippers for the intended use of reduction of chemotherpay induced alopecia, onycholysis and skin toxicity. the devices are misbranded for use during chemotherapy treatments, and may lead to frostbite to digits on patients with, but not limited to diabetic neuropathy, raynaud's disease, distal metastasis, distal arteriopathy and cold intolerance. there have been reports of serious injuries overseas as a result of this issue.
  • Acción
    Control Medics is advising customers to discontinue use of affected products immediately. Customers are advised to quarantine all affected stock to prevent further use and return it to Control Medics.

Device

Hypothermia Caps, Mittens and Slippers
  • Modelo / Serial
    Hypothermia Caps, Mittens and SlippersProduct Name: Hypothermia CapProduct Number: cap-610Batch Number: 052016C Product Name: Hypothermia SlippersProduct Number: SL3000Batch Number: 041116DProduct Name: Hypothermia MittsProduct Number: TM7008Batch Number: 042016CARTG Number: 272254 (cancelled)
  • Manufacturer
    Control Medics Pty Ltd

Manufacturer

Control Medics Pty Ltd
  • Source
    DHTGA