Events

Retiro De Equipo (Recall) de MENTOR Gel Sizers (Sizer for mammary prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-00600-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-04
  • 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-00600-1
  • 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
    A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a mentor gel sizer manufactured at mentor leiden. during the bounding investigation, a second lot was identified as having a style discrepancy between pad print (moderate profile, mp) and all other product labelling (moderate plus, m+). misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
  • Acción
    Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.

Device

MENTOR Gel Sizers (Sizer for mammary prosthesis)
  • Modelo / Serial
    MENTOR Gel Sizers (Sizer for mammary prosthesis)Product Code: RSZ5501 Lot Number: 6680501Product Code: RSZ2751Lot Number: 6749298ARTG Number: 157489
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd