Events

Retiro De Equipo (Recall) de Coloplast Restorelle

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Coloplast A/S.

¿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
    19111
  • Fecha de inicio del evento
    2015-09-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Culpan Distributors Ltd, Unit 10, 19 Hannigan Drive, Mt Wellington, Auckland
  • Causa
    Following a tga review, coloplast pty ltd has made significant and substantive updates to the instructions for use (ifu) for the referenced products. additional contraindications, warnings, and precautions have been added to present the most comprehensive and up to date information available., the key messages include the importance of:, - appropriate patient selection;, - surgeon experience; and, - the need for fully informed patient consent.
  • Acción
    Instructions for use to be updated

Device

Coloplast Restorelle
  • Modelo / Serial
    Model: All models, Affected: All lots
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S