Events

Alerte De Sécurité sur TheraSphere Yttrium 90 Glass Microspheres

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Biocompatibles UK.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-09-23
  • Date de publication de l'événement
    2015-09-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biocompatibles uk therasphere yttrium 90 glass microspheres medical device manufacturer, biocompatibles uk (btg), has issued a medical device safety alert concerning its therasphere yttrium 90 (y-90) glass microspheres. the affected products are identified as follows:- lot number: 1599211; manufacturing date: 03-sep-2015; calibration date: 06-sep-2015; expiry date: 18-sep-2015 the manufacturer has recently become aware, via a customer complaint, of the mislabeling of one dose vial of therasphere y-90 glass microspheres lot 1599211 that was distributed in hong kong. the therasphere vial was labeled 10 gbq and the actual dose was 5 gbq (total radioactivity was incorrect). mislabelling of the therasphere y-90 glass microspheres may result in under- or over-dosing of the patient resulting in the patient not receiving their prescribed dose. under-dosing could result in lack of efficacy, and over-dosing could result in non-target tissue radiation. the manufacturer advises users to verify the accuracy of the dose measurement prior to administration. this recommendation is consistent with the therasphere training and reference material that the manufacturer provides to each user. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

TheraSphere Yttrium 90 Glass Microspheres
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biocompatibles UK TheraSphere Yttrium 90 Glass Microspheres
  • Manufacturer
    Biocompatibles UK

Manufacturer

Biocompatibles UK
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    DH