Events

Alerte Ou Avis De Sécurité sur TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer

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 CooperSurgical under different brand names.

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/2015/025
  • Date
    2015-07-06
  • Date de publication de l'événement
    2015-07-06
  • 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/transwarmer-infant-transport-mattress-novaplus-transwarmer-infant-heat-therapy-mattress-with-warmgel-infant-heel-warmer-risk-of-serious-burn
  • 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
  • Cause
    (coopersurgical under different brand names) risk of serious burn if device is used past its expiry date (mda/2015/025).
  • Action
    Identify and quarantine all product that does not have a lot or expiry date on the packaging (check the transport mattress field safety notice (FSN) and heel warmer FSN. Discard or return affected product to your supplier. Return the relevant acknowledgement and receipt form to the manufacturer.

Device

TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with Wa...
  • Modèle / numéro de série
  • Description du dispositif
    MattressesPackage label Part Product description CooperSurgical 20421 TransWarmer® infant transport mattress NovaPlus V6390 NovaPlus TransWarmer® infant heat therapy mattress with WarmGel®Heel warmersPackage label Part Product description CooperSurgical 20418 WarmGel infant heel warmer CooperSurgical 24401 Liquid infant heel warmer Fisher Brand 24647 FISHERBRAND gel infant heel warmer Fisher Brand 24646 FISHERBRAND liquid infant - heel warmer MediChoice 24649 MEDICHOICE warmgel infant heel warmer MediChoice 24648 MEDICHOICE liquid infant - heel warmer NovaPlus V6391 WARMGEL infant heel warmer - NOVAPLUS NovaPlus V6393 Liquid infant heel warmer - NOVAPLUS
  • Manufacturer
    CooperSurgical under different brand names

Manufacturer

CooperSurgical under different brand names
  • Adresse du fabricant
    CooperSurgical Attn: Product Surveillance 75 Corporate Dr Trumbull CT 06611, USA USA phone: +1 203-601-5200 ext. 3414 USA fax: +1 203-601-9870Email: productsurveillance@coopersurgical.comEuropean Authorised Representative – Emergo Europe Telephone: +31 70 346 7299Email: vigilance@emergogroup.com
  • Société-mère du fabricant (2017)
    The Cooper Companies, Inc.
  • Source
    MHRA