Events

Retiro De Equipo (Recall) de EndoBarrier Gastrointestinal Liner 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-2015-RN-00990-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-12
  • 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-2015-RN-00990-1
  • 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
    This hazard alert notification is intended to ensure that an appropriate communication is made to all customers regarding early termination of the endo trial investigational device exemption (ide) study in the united states (u.S.) and a change in rate of hepatic abscess observed globally.Due to the incidence rate of hepatic abscess (ha) in the u.S. ide endo trial exceeding the established safety threshold of 2%, the study was terminated by gi dynamics prior to completion.This notice serves to remind users of the signs of ha and request that clinicians raise the awareness of the clinical symptoms and signs of ha in their patients as early detection will reduce the severity and sequelae of ha should it arise.Please continue to educate patients on the early signs of ha (e.G., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek medical attention for immediate treatment and resolution to mitigate any complications should they be present.
  • Acción
    This notice serves to remind all users of the signs of HA and to request that clinicians raise the awareness of the clinical symptoms and signs of HA in their patients as early detection will reduce the severity and sequelae of HA should it arise. Please continue to educate patients on the early signs of HA (e.g., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek medical attention for immediate treatment and resolution to mitigate any complications should they be present. Report all adverse incident cases of HA to both GI Dynamics and the TGA. For further infromation, please see http://www.tga.gov.au/alert/endobarrier-duodenal-jejunal-bypass-liner-delivery-system . This action has been closed-out on 19/08/2016.

Device

EndoBarrier Gastrointestinal Liner System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia