Events

Retiro De Equipo (Recall) de TOPPER Xtra Absorbent Dressing Pads, Sterile

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por KCI Medical 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-2014-RN-00893-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-21
  • 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-2014-RN-00893-1
  • 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 manufacturer, systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection.
  • Acción
    Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016.

Device

TOPPER Xtra Absorbent Dressing Pads, Sterile
  • Modelo / Serial
    TOPPER Xtra Absorbent Dressing Pads, Sterile Product codes: P55263 and P55264 – all pack sizesAll lots affectedARTG number: 168750
  • Manufacturer
    KCI Medical Australia Pty Ltd

Manufacturer

KCI Medical Australia Pty Ltd