BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUK

    MDR report key: 5331726 · Received December 29, 2015

    Report

    Report Number
    2110540-2015-00001
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    November 29, 2015
    Report Date
    December 29, 2015
    Manufacturer
    NUK USA LLC
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO POURING HOT WATER INTO THE TANK OF THE HUMIDIFIER WHICH IS A MISUSE / ABUSE OF THE PRODUCT AND A DIRECT VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED.

    Description of Event or Problem · 1

    CONSUMER IS ALLEGING THAT HIS HUMIDIFIER'S TANK EXPLODED AFTER HE FILLED IT WITH HOT WATER AND THAT THE HOT WATER BURNED HIS ARM AND CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855323 NUK COOL MIST HUMIDIFIER KFZ NUK USA LLC 78103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other