BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2180662 · Received July 21, 2011

    Report

    Report Number
    1314800-2011-00032
    Event Type
    Other
    Date Received
    July 21, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 18, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HER HEATING PAD CAUGHT FIRE WHILE IN USE RESULTING IN BURNS TO HER FOOT. SHE STATED SHE HAD THE HEATING PAD PLACED UNDER HER LEG AT THE TIME OF THE EVENT. THIS TYPE OF USE IS CONTRARY TO PROPER USE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other