BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1640194 · Received March 19, 2010

    Report

    Report Number
    1314800-2009-00042
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    January 22, 2009
    Report Date
    March 10, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED IN TO REPORT THAT HER HEATING PAD OVERHEATED, BURNED A HOLE IN HER BED, AND CAUSED A BURN TO HER BOYFRIEND'S BACK. CONSUMER DID NOT STATE IF HE SOUGHT MEDICAL ATTENTION. THE INSTRUCTIONS FOR PROPER USE OF THE HEATING PAD STATE THEY ARE NOT TO BE USED WHILE IN BED OR LAID UPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other