Events

Alerta De Seguridad O Notificaciones De Seguridad para TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por CooperSurgical under different brand names.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2015/025
  • Fecha
    2015-07-06
  • Fecha de publicación del evento
    2015-07-06
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    (coopersurgical under different brand names) risk of serious burn if device is used past its expiry date (mda/2015/025).
  • Acción
    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...
  • Modelo / Serial
  • Descripción del producto
    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
  • Dirección del fabricante
    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
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    MHRA