Events

Retiro De Equipo (Recall) de GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Heraeus Dental 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-00497-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-07
  • 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-00497-1
  • 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 have received reports about single syringes of these lot showing more than usual jerky extrusion behaviour. in one case this led to a fluid ejection from the syringe in front of a hygienist when pushing harder on the plunger rod outside the mouth. if uncontrolled fluid ejection from the syringe occurs, especially the dental patient could be exposed to the gel reaching the mucosa, the face or even the eyes causing irritation, chemical burns and blistering of the tissues which is a medically reversible condition.
  • Acción
    Customers are advised to search their inventory and immediately quarantine any GLUMA Desensitizer PowerGel stock with the affected lot numbers. Stop using the affected products and return the product to the distributor. This action has been closed-out on 11/02/2016.

Device

GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent)
  • Modelo / Serial
    GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent)Article Numbers: 66043451, 66052803Syringe Lot Numbers: 10103, 10104Assortment Lot Numbers: 42, 43, 44, 45, 46, 47, 48, 49, 50, 51Expiry Date: 09/2015ARTG number: 92714
  • Manufacturer
    Heraeus Dental Australia Pty Ltd

Manufacturer

Heraeus Dental Australia Pty Ltd
  • Source
    DHTGA