Events

Alerte De Sécurité sur 3d revascularization device

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

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
    2017-07-24
  • Date de publication de l'événement
    2017-07-24
  • 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_20170724.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: penumbra 3d revascularization device the united states food and drug administration (fda) has issued a medical device safety alert concerning penumbra 3d revascularization device, manufactured by penumbra inc. [lot numbers: c00644, c00645, c00646, c00717; distribution dates: 15 may 2017 to 7 june 2017; manufacturing dates: 21 march 2017 to 28 april 2017] the manufacturer is recalling the penumbra 3d revascularization device because there is a risk of the delivery wire breaking or separating during use. fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. this can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death. affected users are advised to identify and remove any affected 3d revascularization devices from inventory and quarantine. for details, please refer to the fda websites: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm567913.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm567990.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 july 2017.

Device

3d revascularization device
  • Modèle / numéro de série
  • Classification du dispositif
    Neurological Devices
  • Description du dispositif
    Medical Device Safety Alert: Penumbra 3D Revascularization Device
  • Manufacturer
    Penumbra Inc

Manufacturer

Penumbra Inc