Events

Alerte De Sécurité sur Onyx Liquid Embolic System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par ev3.

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
    2012-07-03
  • Date de publication de l'événement
    2012-07-03
  • 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_20120703f.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: ev3 onyx liquid embolic system the united states food and drug administrations (fda) has issued a safety communication concerning the onyx liquid embolic system, manufactured by ev3. the fda notified physicians and patients about the risk of catheter entrapment associated with the use of onyx. catheter entrapment happens when the catheter becomes stuck in the implanted onyx material. complications of catheter entrapment include migration of the onyx plug or catheter fragment to other parts of the body, haemorrhage and death. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/medwatch/safetyinformation/safety alertsforhumanmedicalproducts/ucm310199.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 july 2012.

Device

Onyx Liquid Embolic System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ev3 Onyx Liquid Embolic System
  • Manufacturer
    ev3

Manufacturer

ev3
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH