BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2042229 · Received March 30, 2011

    Report

    Report Number
    1314800-2011-00015
    Event Type
    Other
    Date Received
    March 30, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 23, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER CALLED TO REPORT RECEIVING BURNS TO HER BACK WHILE USING THE HEATING PAD. SHE CLAIMS SHE HAD A NUMBER OF BLISTERS AND THE AREA WAS VERY RED. SHE FELL ASLEEP WHILE LAYING ON THE HEATING PAD, THE OWNER'S MANUAL INSTRUCTS NOT TO LAY OR LEAN AGAINST THE HEATING PAD.

    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 UNK Other