Events

Retiro De Equipo (Recall) de Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling

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-2017-RN-01542-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-12-21
  • 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-2017-RN-01542-1
  • 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
    On november 28, 2017, the therapeutic goods administration (tga) notified coloplast of tga’s decision to remove transvaginal mesh products used to treat pelvic organ prolapse (pop), and single incision mini-slings from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.Following this direction from tga, coloplast is recalling all restorelle directfix anterior, restorelle directfix posterior, and altis single incision sling products from the australian market.No other coloplast devices are affected by this recall.
  • Acción
    Coloplast is advising hospitals to quarantine any affected product for return to Coloplast. Instructions for product return are provided on the Customer Letter issued to affected customers.

Device

Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling
  • Modelo / Serial
    Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision SlingRestorelle DirectFix AnteriorModel/Catalogue Number: 501450SKU Number: 5014501022ARTG 190172Restorelle DirectFix PosteriorModel/Catalogue Number: 501460SKU Number: 5014601022ARTG 190172Altis Single Incision Sling SystemModel/Catalogue Number: 519650SKU Number: 5195601022ARTG 190173
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd