Events

Alerte De Sécurité sur Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide

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

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
    2014-12-16
  • Date de publication de l'événement
    2014-12-16
  • 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_20141216.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: owen mumford autopen, autopen 24, densupen and autopen 3ml for teriparatide the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning autopen classic, autopen 24, densupen and autopen 3ml for teriparatide manufactured by owen mumford ltd. the affected product codes are an3800, an3810, an4200, an4210, an1281 and an1251. according to the manufacturer, a proportion of devices from the lot codes listed in the field safety notice have a potential mechanical fault. the fault presents itself in the following ways: a) a dose may be dialled-up but the dose selector will not hold that dose and instead will spin straight back to zero. b) the dose may be dialled-up and the dose selector will hold the dose momentarily, but will then spin back to zero. this potential risks to patient are: a) the patient will not be able to use the pen, no dose can be delivered. b) the patient may only receive a partial dose and will not know how much insulin has been delivered. the affected products are being recalled. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 december 2014.

Device

Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Owen Mumford Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide
  • Manufacturer
    Owen Mumford Ltd

Manufacturer

Owen Mumford Ltd