Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Culpan Medical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00865-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00865-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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