BEUDAMED
    FDA Adverse Event Summary report: N

    ELECTRICAL STIMULATION UNIT

    MDR report key: 19478 · Received December 13, 1994

    Report

    Report Number
    MW1400628
    Date Received
    December 13, 1994
    Date of Event
    November 11, 1994
    Report Date
    December 13, 1994
    Manufacturer
    AMEREX-ZETRON, INC.
    Product Code
    IPF
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 3RD DEGREE BURNS ON HER FOOT (APPROX 1 X 2 CENTIMER AREA) WHILE BEING TREATED WITH AN ELECTRICAL STIMULATION UNIT FOR INFLAMMATION OF FOOT TISSUE. DR STATED THE PT NOW HAS POOR CIRCULATION IN THE FOOT AND MAY NEED ADD'L TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRICAL STIMULATION UNIT IPF AMEREX-ZETRON, INC. IF-150

    Patients

    Seq Age Sex Outcome Treatment
    1 *