Events

Retiro De Equipo (Recall) de Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix Anterior

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Coloplast 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-00748-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-02
  • 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-2015-RN-00748-1
  • 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 tga carried out a clinical review of urogynaecological surgical mesh implants and found that, while there may be a benefit in certain patients there is little evidence to support the overall effectiveness of these surgical meshes as a class of products.The findings from the review have highlighted the importance of:- appropriate patient selection;- surgeon experience; and- the need for fully informed patient consent.Following the tga's 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.
  • Acción
    Coloplast is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for their range of urogynaecological meshes.. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 12/08/2016.

Device

Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRest...
  • Modelo / Serial
    Coloplast urogynaecological surgical meshAris KitARTG Number: 157074Altis SystemARTG Number: 190173Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix AnteriorARTG Number: 190172
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd