Events

Alerta De Seguridad para Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Owen Mumford Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-12-16
  • Fecha de publicación del evento
    2014-12-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141216.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Owen Mumford Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide
  • Manufacturer
    Owen Mumford Ltd

Manufacturer

Owen Mumford Ltd