BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEXOMA MEDIC

    MDR report key: 4672583 · Received April 5, 2015

    Report

    Report Number
    MW5042001
    Event Type
    Injury
    Date Received
    April 5, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 5, 2015
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GOOD MORNING, I RECEIVED THE ELEXOMA MEDIC DEVICE FROM (B)(6) AND STARTED ON WEDNESDAY EVENING A FIRST CES SESSION (25MIN AT 200UAMP). EVERYTHING WORKED AS MENTIONED ON THE MANUAL WITH THE BIP WHEN I STARTED THE DEVICE AND WHEN I REACHED 200UAMP. I ALSO PUT SOME WATER ON THE EAR-CLIPS JUST BEFORE TO USE THEM. I DIDN'T FEEL ANYTHING SPECIAL DURING THE SESSION. HOWEVER, I WOKE UP IN THE MIDDLE OF THE NIGHT (ABOUT 3-4H AFTER THIS SESSION) WITH A VERY STRANGE FEELING IN MY RIGHT EAR (LIKE IF SOMETHING WAS PULSING). NOW, I HEAR LESS FROM THIS EAR AND HAVE THE SAME SENSATION AS AFTER A FLIGHT WHEN EARS ARE BLOCKED/CLOGGED. I WENT TO THE MEDICAL DOCTOR AND IT SEEMS THAT MY INTERNAL EAR IS DAMAGED. I STARTED TO TAKE CORTISONE. IN ADDITIONAL TO THIS PROBLEM I WAKE UP EVERY NIGHT AROUND 1 AM WITH VERY BIG FEAR. I NEVER HAD THIS BEFORE AND CANNOT SLEEP ANYMORE. IN CONCLUSION, I USED THE ELEXOMA DEVICE FOR ANXIETY AND AFTER ONE SESSION I HAVE PROBLEM WITH MY EAR, PANIC ATTACK DURING THE NIGHT AND DON'T SLEEP ANYMORE AT NIGHT. IT IS THE OPPOSITE EFFECT REGARDING WHAT IS DESCRIBED ON YOUR INTERNET HOMEPAGE. PLEASE COULD YOU GIVE ME YOUR FEED-BACK ON THESE ISSUES AND SOME ADVICE TO HELP ME. IT'S A NIGHTMARE. I HAVE NEVER BEEN FEELING SO BAD. THANK YOU IN ADVANCE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224516 ELEXOMA MEDIC STIMULATOR JXK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability