BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2120463 · Received May 27, 2011

    Report

    Report Number
    1314800-2011-00021
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS TO HER STOMACH FROM THE HEATING PAD. SHE ALLEGED THE BURNS RESULTED IN BLISTERS FOR WHICH SHE SOUGHT MEDICAL ATTENTION. THE CONSUMER STATED THE WARNING LIGHT ON THE HEATING PAD WAS FLASHING PRIOR TO THE INCIDENT.

    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