Retiro De Equipo (Recall) de Counterfeit Durex branded condoms purchased from Groupon website

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Groupon 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-2015-RN-00346-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-17
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 durex branded condoms sold by edgelounge enterprises pty ltd (trading as citrus beat) on groupon australia's website between 12.03.2015 to 10.04.2015 are counterfeit goods with defects such as holes in the latex and they may fail.
  • Acción
    Groupon Australia is informing the customers not to use these condoms and destroy or dispose them or return them for a full refund. For more information, please see the TGA web statement published at http://www.tga.gov.au/alert/counterfeit-durex-branded-condoms-purchased-groupon-website . This action has been closed-out on 19/10/2016.

Device

  • Modelo / Serial
    Counterfeit Durex branded condoms purchased from Groupon websiteSold between 12.03.2015 to 10.04.2015.
  • Manufacturer

Manufacturer