BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEC 922ST 2"X2" SQ

    MDR report key: 3759275 · Received April 18, 2014

    Report

    Report Number
    1721293-2014-00002
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    EMPI, INC
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODES WERE INVESTIGATED AND WERE FOUND TO BE WITHIN SPECIFICATIONS AND NO FAILURES WERE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED ON HER RIGHT FOOT DURING A TREATMENT USING CARBON CLOTH ELECTRODES. THE PATIENT WAS BEING TREATED FOR PAIN AND EDEMA. SHE HAS SOME MILD EDEMA PRESENT. THE DEVICE USED WAS A CLINICAL UNIT, NOT AN EMPI DEVICE. THE TREATMENT PROGRAM WAS INTERFERENTIAL, THE INTENSITY USED WAS 35 V CV, THE CYCLE TIME USED WAS CONTINUOUS, AND THE TREATMENT TIME WAS 15 MINUTES. CHANNELS 1 AND 2 WERE USED. THE ELECTRODES WERE SAID TO BE PLACE APPROXIMATELY 5 INCHES APART. THE PATIENT HAD NO COMPLAINTS OF PAIN OR DISCOMFORT DURING THE TREATMENT. THE BURNS WERE NOTICED IMMEDIATELY UPON REMOVAL OF THE ELECTRODES. THERE WAS AN 18" X 12" ICE PACK OVER THE ANKLE BUT THE PHYSICAL THERAPIST STATED THAT THE ICE PACK RESTED MOSTLY ON THE BED WITH VERY LITTLE PRESSURE/WEIGHT ON THE ANKLE. NOTHING WAS PLACED OVER THE ICE PACKS. THERE WERE THREE "BURNS" CAUSED BY TWO ELECTRODES. THEY NOTED THAT THE BURNS WERE AT OR VERY NEAR THE AREA WHERE THE PIGTAIL INSERTS INTO THE ELECTRODE. THE PATIENT SAW HER WOUND CARE PHYSICIAN IMMEDIATELY AFTER HER PHYSICAL THERAPIST VISIT FOR AN UNRELATED WOUND. THE DOCTOR OBSERVED THE BURNS BUT DID NOT TREAT THEM. THE PHYSICAL THERAPIST STATED THAT THE PATIENT HAS SOME NEUROPATHY AND SO THE CLINICIAN WAS CAREFUL NOT TO TURN UP THE DEVICE TOO HIGH AND KEPT THE SAME PARAMETERS AS THE PREVIOUS 3 TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237946 ELEC 922ST 2"X2" SQ 2X2 CARBON CLOTH ELECTRODES GXY EMPI, INC 199327-001 325445

    Patients

    Seq Age Sex Outcome Treatment
    1 46 Other