BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMCARE ELECTRODE 2" X 2"

    MDR report key: 5081705 · Received September 16, 2015

    Report

    Report Number
    1721293-2015-00005
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 21, 2015
    Manufacturer
    EMPI, INC
    Product Code
    GXY
    PMA / PMN Number
    K902195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODES WERE NOT RETURNED FOR EVALUATION. ELECTRODES WERE DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED BURNS UNDER THE ELECTRODE DURING TREATMENT. THE TREATMENT WAS FOR LOW BACK PAIN. THE PROGRAM USED WAS A IFC, THE INTENSITY USED WAS 10-20, MODE USED WAS SWEEP, AND CYCLE TIME USED WAS 80-150 PPS. THE TREATMENT WAS FOR 15 MINUTES. THE ELECTRODES WERE USED FOR 4 TREATMENTS. THERE WAS PRESSURE APPLIED TO THE ELECTRODES AT THE TIME OF TREATMENT. THE ELECTRODES WERE PLACED 6 INCHES APART. THE PATIENT'S PROGRESS TOWARD RECOVERY WAS NOT IMPEDED DUE TO THIS INCIDENT. THE BURNS WERE 1CM X 1CM SUPERFICIAL, AND THE BURN WAS DIAGNOSED AS A SECOND DEGREE BURN, THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614262 STIMCARE ELECTRODE 2" X 2" STIMCARE ELECTRODE GXY EMPI, INC 199327-001 516355

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other