BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2469287 · Received February 14, 2012

    Report

    Report Number
    1314800-2012-00006
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 8, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVED 2ND DEGREE BURNS TO HER HIP AFTER LAYING ON THE HEATING PAD. SHE STATED IN HER REPORT THAT SHE DOES NOT ALWAYS FEEL HEAT RIGHT AWAY DUE TO HER MULTIPLE SCLEROSIS. THE OWNERS MANUAL WARNS AGAINST USING THE HEATING PAD IF YOU SUFFER FROM ANY TYPE OF ISSUE WHERE YOU EXPERIENCE A LACK OF SENSATION AS WELL AS TO NOT 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. HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other