Events

Retiro De Equipo (Recall) de Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-2017-RN-00328-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-06
  • 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-00328-1
  • 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
    Cook medical is instigating a change in the intended use wording of the product instructions for use (ifu). this change is in response to the report of two potential adverse events during use in urological or gynecological procedures. this change will provide clarification of the product's intended use, with the addition of the following statement in the ifu: "this device is not intended for use in urological or gynaecological procedures".
  • Acción
    Cook is advising users of an update to the intended use in the instructions for use to clarify that the devices are not intended for use in urological or gynaecological procedures. A new version of the instructions for use that includes the updated intended use will be introduced within the next few months. In the interim, each device will be supplied with a leaflet that includes notice of the update.

Device

Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft
  • Modelo / Serial
    Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue GraftCook Biodesign 1-Layer Tissue Graft Model Numbers: C-SLH-1S-2X3, C-SLH-1S-7X10, SLH-1S-7X10Cook Biodesign 4-Layer Tissue GraftModel Numbers: C-SLH-4S-1X10, C-SLH-4S-2X3, C-SLH-4S-4X7, C-SLH-4S-7X10, C-SLH-4S-7X20, J-SLH-4S-7X20, J-SLH-4S-4X7, J-SLH-4S-7X10, SLH-4S-2X3, SLH-4S-3.5X5, SLH-4S-4X7, SLH-4S-7X10, SLH-4S-7X20ARTG Number: 153047
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd