BEUDAMED
    FDA Adverse Event Other Summary report: N

    9000 SERIES TENS/NMES ELECTRODES

    MDR report key: 378958 · Received February 25, 2002

    Report

    Report Number
    378958
    Event Type
    Other
    Date Received
    February 25, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 20, 2002
    Manufacturer
    EMPI
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DISCOVERTED 5 SMALL BURNS ON RIGHT KNEE AFTER ELECTRICAL STIMULATION TREATMENT IN THE OUTPATIENT PHYSICAL THERAPY DEPT. THE BURNS WERE DISCOVERED AT HOME BY THE PT LESS THAN 2 HOURS AFTER TREATMENT. PT WAS SEEN AT THE ER THE FOLLOWING DAY AND REFERRED TO THE WARD HEALING CENTER AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9000 SERIES TENS/NMES ELECTRODES ELECTRODES USED WITH ELECTRICAL STIMULATOR GZJ EMPI 9000 SERIES 041125108

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other DYNATRON 500, MODEL #500, ELECTRICAL RATING,| SLOW BURN 250V.| VOLTS-115, HERTZ-60, AMPS-1.2, FUSE 1.6 AMP,