Events

Retiro De Equipo (Recall) de NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A, B or CARTG Number: 124725

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Novo Nordisk Pharmaceuticals 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-00650-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-04
  • 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-00650-1
  • 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
    Internal investigations have concluded that a component supplier change led to a minor change in the shape of the metal thread which joins the mechanical section to the cartridge holder. as a result, the metal thread on the mechanical section is more likely to cut into the plastic thread inside the cartridge holder resulting in increased resistance during assembly. increased resistance during assembly can result in a patient assuming a pen is correctly assembled when it is not, which could result in under dosing.
  • Acción
    Novo Nordisk are providing health care professionals and consumers with clarified instructions for the assembly of the Nordipen. For more details, please see http://www.tga.gov.au/safety/alerts-device-nordipen-130723.htm

Device

NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A...
  • Modelo / Serial
    NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridgesLot numbers beginning with A, B or CARTG Number: 124725
  • Manufacturer
    Novo Nordisk Pharmaceuticals Pty Ltd

Manufacturer

Novo Nordisk Pharmaceuticals Pty Ltd