Events

Retiro De Equipo (Recall) de Peristeen Anal Irrigation System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Coloplast 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-2014-RN-00087-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-17
  • 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-2014-RN-00087-1
  • 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
    Following the publication of a review article on the best practice of transanal irrigation in adults, and post-market surveillance coloplast has decided to update the instructions for use. the update includes changes to the sections indication, contraindications, precautions, warnings and introduces instruction for more thorough patient examination before starting anal irrigation treatment. the potential risks that may result from the use of the device have not changed and there are no changes or modifications to the peristeen anal irrigation system.
  • Acción
    Coloplast is writing to all hospitals and patients to inform them of the updates to the instructions for use. Further information on this issue has been provided on the TGA website at - http://www.tga.gov.au/safety/alerts-device-peristeen-anal-irrigation-system-140219.htm#.UwWXnbTTQgs

Device

Peristeen Anal Irrigation System
  • Modelo / Serial
    Peristeen Anal Irrigation SystemAll lot numbers affectedARTG Number: 135449
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd