BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2498361 · Received March 14, 2012

    Report

    Report Number
    1314800-2012-00011
    Event Type
    Other
    Date Received
    March 14, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 12, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE RECEIVING A BURN FROM THE HEATING PAD. HE RECEIVED A SMALL BURN TO HIS RIGHT HAND WHICH RESULTED IN A SMALL SCAR. THE CONSUMER STATED HE HAS SLEEPING WITH THE HEATING PAD AT THE TIME OF THE INCIDENT WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other