Events

Retiro De Equipo (Recall) de Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Merck Serono 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-00908-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-04
  • 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-00908-1
  • 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
    The easypod injection device requires programming prior to supply to ensure the patient receives the correct dose. with the interruption in the supply of saizen solution for injection, devices required reprogramming to take into consideration the change in concentration from either 5.83 mg/ml or 8 mg/ml available in the solution for injection presentations to only 5.83 mg/ml in the click.Easy powder for injection presentation. to mitigate against the risk of a patient receiving an incorrect dose due to their device not having been reprogrammed as required, merck serono is recalling the current easypod device and replacing it with a new model. the newer model (model 5.2) will not proceed to injection if the cartridge in the device does not match the programmed settings. further, this feature cannot be over-ridden by the patient representing an improvement on the cartridge recognition feature in the current model (model 5.1).
  • Acción
    Merck Serono is contacting clinicians and pharmacists of patients under the PBS Growth Hormone Program for replacing the Easypod auto injector model 5.1 with model 5.2. Merck Serono is contacting private patients affected and asking them to get the replacement devices from their pharmacies. In the meantime, customers are asked not to stop using SAIZEN and continue with the treatment as directed by their doctor. For more details, please see http://www.tga.gov.au/safety/alerts-device-easypod-auto-injector-130906.htm .

Device

Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)
  • Modelo / Serial
    Easypod Auto Injector, model 5.1 (Used to inject SAIZEN growth hormone under the skin)ARTG Number: 168234
  • Manufacturer
    Merck Serono Australia Pty Ltd

Manufacturer

Merck Serono Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Merck KGaA
  • Source
    DHTGA