BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERTHERMIA UNITS

    MDR report key: 503339 · Received December 17, 2003

    Report

    Report Number
    MW1030565
    Event Type
    Malfunction
    Date Received
    December 17, 2003
    Date of Event
    November 15, 2003
    Report Date
    December 10, 2003
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYPERTHERMIA UNIT CAUSED AREA OF MULTIPLE BLISTER ON LEFT HIP AND BUTTOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERTHERMIA UNITS HYPERTHERMIA UNITS DWJ GAYMAR INDUSTRIES, INC. TP500C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *