BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1697366 · Received May 18, 2010

    Report

    Report Number
    1314800-2010-00023
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 11, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED RECEIVING A BLISTER FROM USE OF HIS HEATING PAD. HE WAS LAYING ON THE PAD AT THE TIME OF THE INCIDENT AND THE PAD SLIPPED OUT OF IT'S COVER RESULTING IN THE BURN. LAYING ON THE HEATING PAD IS CONTRARY TO PROPER USE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other