Events

Safety Alert Or Field Safety Notices for TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by CooperSurgical under different brand names.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2015/025
  • Date
    2015-07-06
  • Event Date Posted
    2015-07-06
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • Reason
    (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...
  • Model / Serial
  • Product Description
    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
  • Manufacturer Address
    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
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    MHRA