Events

Alerte De Sécurité sur neuron max catheters

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
    2013-10-28
  • Date de publication de l'événement
    2013-10-28
  • 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_20131028.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 neuron max catheters medical device manufacturer, penumbra inc., has issued a medical device safety alert concerning neuron max catheters. the affected catalogue numbers are as follows: pnmd8f088804m - 8f 088 neuron max 088 delivery catheter 80/4 mp pnmd8f088904m - 8f 088 neuron max 088 delivery catheter 90/4 mp pnml6f088804m - 6f 088 neuron max long sheath 80/4 mp pnml6f088904m - 6f 088 neuron max long sheath 90/4 mp pnml6f0881004m - 6f 088 neuron max long sheath 100/4 mp the manufacturer has recently identified that, for some neuron max catheters, it is possible for the packaging mandrel to remain within the catheter during removal. when this occurs, the catheter tip can be damaged. this is due to reduced adherence of the mandrel to the packaging card. the manufacturer advises affected users to take the following preventive actions: follow the product instructions for use and remove the device carefully inspect the device prior use to detect any damage has occurred to the product during the removal from the packaging. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

neuron max catheters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Penumbra Neuron MAX Catheters
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.