Events

Alerte De Sécurité sur BioMatrix NeoFlex

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

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
    2013-08-16
  • Date de publication de l'événement
    2013-08-16
  • 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_20130816.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: biosensors biomatrix neoflex it has come to our attention that medical device manufacturer, biosensors, has initiated a field safety corrective action concerning its biomatrix neoflex. in specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action. if not identified prior use, the hub cracking may potentially lead to treatment delays or complications. the manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013. the manufacturer advises users to identify, quarantine and return affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BioMatrix NeoFlex
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosensors BioMatrix NeoFlex
  • Manufacturer
    Biosensors

Manufacturer

Biosensors