BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2469286 · Received February 14, 2012

    Report

    Report Number
    1314800-2012-00009
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 12, 2012
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HEATING PAD MELTED WHILE IN USE CAUSING SECOND DEGREE BURNS TO HER ARM. SHE DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INITIAL PHONE CALL. BURNS OF THIS NATURE OF THE RESULT OF THE CONSUMER PLACING THE HEATING PAD BETWEEN THEMSELVES AND AN SOLID OBJECT WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other