BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3022488 · Received March 15, 2013

    Report

    Report Number
    1314800-2013-00017
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    March 4, 2012
    Report Date
    March 7, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED SHE WAS LAYING ON THE HEATING PAD WITH A TOWEL WHEN THE PAD OVERHEATED CAUSING SECOND DEGREE BURNS TO HER BACK SIDE. THE INSTRUCTIONS FOR PROPER USE STATE NOT TO LAY OR LEAN AGAINST THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110573 SOFTHEAT HEATING PAD IRT KAZ, INC. HP980 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other