Events

Alerte Ou Avis De Sécurité sur Wheeled and non-wheeled walking frames (all models)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Patterson Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2013/060
  • Date
    2013-08-01
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-wheeled-and-non-wheeled-walking-frames-all-models-potential-for-detachment-of-the-wheels-and-or-inadequately-tightened-screws
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    Potential for detachment of the wheels and/or inadequately tightened screws, which may cause the user to fall.Frames of specific batches produced from January 2013 to March 2013 may not have been manufactured to specification.The manufacturer issued a Field Safety Notice (158Kb) in May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information.
  • Cause
    (patterson medical) may cause the user to fall. (mda/2013/060).
  • Action
    Ensure that those responsible for provision and maintenance of these devices:identify affected devices perform the checks and actions detailed in the manufacturer’s Field Safety Notice (158Kb) complete the reply letter and return it to Patterson Medical.

Device

Wheeled and non-wheeled walking frames (all models)
  • Modèle / numéro de série
  • Description du dispositif
    Wheeled and non-wheeled walking frames (all models).Manufactured by Patterson Medical.Batch codes from DMW12013 to DMW82013 inclusive.Note - paediatric walking frames manufactured by Patterson Medical are not affected.
  • Manufacturer
    Patterson Medical

Manufacturer

Patterson Medical
  • Adresse du fabricant
    ManufacturerPatterson Medical Customer Services North Road Bridgend Industrial Estate Bridgend Wales, CF31 3TP Tel:    0844 412 4330 Fax:   0844 873 0100Email:    retail.sales@pattersonmedical.com
  • Société-mère du fabricant (2017)
    Performance Health Holdings Inc.
  • Source
    MHRA