Events

Retiro De Equipo (Recall) de EndoBarrier Gastrointestinal Liner with Delivery 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-01320-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-18
  • 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-01320-1
  • 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 assessment of the risk/benefit profile during audit by the notified body, sgs, a review of the company’s historical clinical evidence for the endobarrier has been undertaken. resulting from this review gi dynamics is updating the endobarrier’s indications for use, contraindications and possible adverse events to ensure adequate risk mitigation. the change in indication specifically aims to reflect that the obesity indication includes a restriction to patients with a body mass index (bmi) = 30 kg/m2.
  • Acción
    Emergo is notifying their customers of the additional warnings, contraindications and limitations to the indications. Surgeons are advised that any patients implanted with the device contrary to the additional safety information should be monitored closely for the potential complications and adverse events. The decision to remove the EndoBarrier Gastrointestinal Liner System should take into consideration the patients clinical history in the context of the new information in the IFU. This action has been closed-out on 03/05/2016. For additional information see http://tga.gov.au/alert/endobarrier-gastrointestinal-liner-delivery-system .

Device

EndoBarrier Gastrointestinal Liner with Delivery System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia