BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERFERENTIAL

    MDR report key: 555745 · Received September 9, 2004

    Report

    Report Number
    555745
    Event Type
    Other
    Date Received
    September 9, 2004
    Date of Event
    May 11, 2004
    Report Date
    September 9, 2004
    Manufacturer
    ENRAF-NONIUS B.V.
    Product Code
    KOI
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT REHAB PATIENT SUSTAINED A BURN BY AN ELECTRODE DURING PHYSICAL THERAPY. IT WAS UNKNOWN AT THE TIME OF OCCURRENCE. REPORTED AT THE FOLLOW-UP TREATMENT VISIT. MANAGER FEELS THAT IT WAS NOT A MACHINE MALFUNCTION, THAT THE ELECTRODES LOST CONTACT WITH THE SKIN DUE TO MOVEMENT AND/OR THE TREATMENT AREA. BOTH MACHINES CHECKED BY BIOMED DEPARTMENT AFTER OCCURRENCE. INJURED AREA: RIGHT BUTTOCK, APPROXIMATELY 1 CM WIDTH, VERY NARROW AND 1-2 MM DEPTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFERENTIAL PERIPHERAL NERVE STIMULATOR KOI ENRAF-NONIUS B.V. ENDOMED M 433 *
    2 INTERFERENTIAL PERIPHERAL NERVE STIMULATOR KOI ENRAF-NONIUS ENDOMED 433 MODEL/PART 1433.902
    3 GENTLE STIM R PLUS REUSABLE SELF-ADHERING TENS/FES/NMS ELECTRODES WITH PIGTAIL GZJ NATIONAL MEDICAL ALLIANCE PART 42093 25651203184

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR
    2 *
    3 *