Events

Retiro De Equipo (Recall) de Flexi-Seal CONTROL Faecal Management 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 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-2014-RN-00507-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-08
  • 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-00507-1
  • 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
    An internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control faecal management system is not meeting performance requirements for this product. specifically, the auto-valve has not been consistently performing relative to the inflation and deflation of the device’s retention balloon. in the event that the auto-valve does not perform properly related to inflation and deflation of the device’s retention balloon, there is the potential that medical intervention may be necessary. in accordance with the instructions for use supplied with the flexi-sealtm controltm faecal management system, the following events could occur:- leakage of stool around the device, and peri-anal skin breakdown;- rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa;- perforation of the bowel.
  • Acción
    End users are advised to stop the use of all affected devices and return all affected products to their distributor for credit or replacement with unaffected product.

Device

Flexi-Seal CONTROL Faecal Management System
  • Modelo / Serial
    Flexi-Seal CONTROL Faecal Management SystemProduct code: 411107All lot numbersARTG number: 163198
  • Manufacturer
    Convatec Australia Pty Ltd

Manufacturer

Convatec Australia Pty Ltd