BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 650013 · Received November 30, 2005

    Report

    Report Number
    MW1037329
    Event Type
    Other
    Date Received
    November 30, 2005
    Date of Event
    October 18, 2005
    Report Date
    November 30, 2005
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE PRODUCT, THE USER FELL ASLEEP AND SUSTAINED SERIOUS BURNS REQUIRING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HF110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other