BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT HEATING PAD

    MDR report key: 1628714 · Received March 5, 2010

    Report

    Report Number
    1314800-2010-00011
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 2, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER RECEIVED 2ND DEGREE BURNS FROM THE HEATING PAD. THE PAD OVERHEATED DUE TO MISUSE, THE CONSUMER WAS LAYING ON THE PAD IN HER BED WHICH IS CONTRARY TO PROPER USE INSTRUCTIONS. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION FOR BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD HEATING PAD IRT KAZ, INC. HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other