BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ

    MDR report key: 5137581 · Received July 13, 2004

    Report

    Report Number
    1314800-2004-00009
    Event Type
    Other
    Date Received
    July 13, 2004
    Date of Event
    March 30, 2004
    Report Date
    July 13, 2004
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED UNDERGOING A DOUBLE MASTECTOMY, THEN USING A MICROWAVE HEATED PAD FOR RELIEF. CONSUMER INDICATED NO FEELING IN AREA OF APPLICATION. CONSUMER REPORTED BURN AFTER USE OF PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ HEAT PAD IRT KAZ, INC. HC1302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other