Events

Retiro De Equipo (Recall) de C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Atrium Australia - Pacific Rim Pty Limited.

¿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-2013-RN-00751-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-26
  • 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-2013-RN-00751-1
  • 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
    Atrium medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. this becomes evident if:- it becomes difficult to peel the mesh from the handling sleeve, or- the yellow coating material separating the mesh is retained on the clear plastic liner.
  • Acción
    Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.

Device

C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)
  • Modelo / Serial
    C-Qur, C-Qur TacShield and C-Qur V-Patch (used for tissue reinforcement during surgery)All lot numbers 10405513 and higherC-QurMultiple Catalogue Numbers affected ARTG Number: 163310C-Qur TacShieldCatalogue Numbers: 31610, 31611, 31612, 31626, 31628, 31633, 31636, 31637, 31638, 31644ARTG Number: 182852C-Qur V-PatchCatalogue Numbers: 31200, 31201, 31202ARTG Number: 174772
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA