Events

Retiro De Equipo (Recall) de PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Culpan 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-2016-RN-00865-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-05
  • 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-2016-RN-00865-1
  • 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
    It was identified that the phil container (syringe) may elute unintended elements (metals) into phil device formulation. this elution may discolour the phil device, or may not change the appearance of the device. at this point no adverse events related to product deficiency or specific patient reactions were reported to the manufacturer. microvention has not currently identified possible risk to patients associated with previous uses of phil devices. culpan medical is in negotiations with the tga regarding the need for any further actions.
  • Acción
    Customers are advised to identify and quarantine all affected devices in their possession and return them to Culpan Medical. Recommended patient follow-up for doctors: continue to collect and report to the Therapeutic Goods Administration and the manufacturer any Adverse Events/Patient Reactions. This action has been closed-out on 10/05/2017.

Device

PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended fo...
  • Modelo / Serial
    PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)Product Codes: LEN10250, LEN10300, LEN10350All Batch Numbers affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Culpan Medical Pty Ltd

Manufacturer

Culpan Medical Pty Ltd