Events

Retiro De Equipo (Recall) de AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por American Medical Systems 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-2013-RN-00230-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-15
  • 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-2013-RN-00230-1
  • 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
    Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in australia were released despite not fully meeting the manufacturer's product release criteria.
  • Acción
    AMS is advising that the risk of prophylactic removal of implanted control pumps outweighs any benefit. Physicians are requested to review the information in the Hazard Alert and use normal clinical practice to determine necessary actions. for more details, please see http://www.tga.gov.au/safety/alerts-device-ams800-controlpump-130326.htm .

Device

AMS 800 Artificial Urinary Sphincter Control PumpsItem numbers (REF): 72400098 and 72404127

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA