Events

Alerte De Sécurité sur Medasil Airway (Guedel type)

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

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
    2015-12-15
  • Date de publication de l'événement
    2015-12-15
  • 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_20151215.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: medasil airway (guedel type) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning medasil airway (guedel type), code 38/2 size 2, manufactured by medasil surgical. the affected product identifiers are lot wh61, consignments 355 and 363, expiry 2019/03. the problem relates to a single device returned to the manufacturer by a user, in which the distal end of the airway was completely blocked. this fault represents a potential serious hazard to patient safety (i.E. suffocation) if the fault is not identified before use in patients. the manufacturer is performing an immediate recall of the affected lot of airway products. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-7-to-11-december-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 december 2015.

Device

Medasil Airway (Guedel type)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medasil Airway (Guedel type)
  • Manufacturer
    Medasil Surgical

Manufacturer

Medasil Surgical