Events

Retiro De Equipo (Recall) de Brennen Skin Graft Mesher - 4.5 and 6.5 inch

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care 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-00536-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-01
  • 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-00536-1
  • 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
    Resulting from a post-market internal investigation, mölnlycke has identified a potential safety issue regarding the current sterilisation validation for the brennen skin graft mesher. with the current sterilisation instructions contained in the instructions for use (ifu), the sterility of the mesher cannot be guaranteed following a sterilisation cycle carried out according to those instructions. given the sterility of the brennen skin graft mesher cannot be guaranteed there is a risk for possible contamination, which may lead to infection. mölnlycke confirms that no product, patient or user complaints have been reported to date for products in australia regarding this issue.
  • Acción
    Mölnlycke is advising users to immediately stop using the Brennen Skin Graft Mesher and apply the tag (i.e. label) provided by Mölnlycke to the device, or otherwise remove the device from service using applicable labelling and/or quarantine measures under the respective in house quality management system. The tag supplied states that the device is out of service and should not be used. Once the new sterilisation parameters have been confirmed by the manufacturer, through further validation testing during May, Mölnlycke will send users the updated IFU defining the new Sterilisation Procedure. This is estimated to occur in June 2017.

Device

Brennen Skin Graft Mesher - 4.5 and 6.5 inch
  • Modelo / Serial
    Brennen Skin Graft Mesher - 4.5 and 6.5 inchProduct Codes: 131500, 131501, 131502, 131503, 131504, 131506, 131600, 131601, 131602, 131603, 131604All Lot NumbersARTG Number: 196830
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd