BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL CO2 LASER

    MDR report key: 3901876 · Received June 23, 2014

    Report

    Report Number
    MW5036884
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    July 2, 2013
    Report Date
    June 20, 2014
    Manufacturer
    LUTRONIC
    Product Code
    EWG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SIX DAYS AFTER A LASER "VITRIFICATION" PROCEDURE ON A FRACTURED RIGHT MANDIBULAR MOLAR TO "PREVENT A ROOT CANAL", I WAS HOSPITALIZED WITH INTRACTABLE VOMITING, ATAXIA, VERTIGO, DIPLOPIA, HEARING LOSS AND OTHER CRANIAL NERVE DEFICITS. I WAS ADMITTED TO THE NEURO INTENSIVE CARE UNIT AND TREATED AS A STROKE PATIENT. SEVEN WEEKS LATER, AFTER DISCHARGE FROM A REHABILITATION HOSPITAL AND BI-WEEKLY PHYSICAL THERAPY SESSIONS MY CONDITION WAS MARKEDLY IMPROVED. UNFORTUNATELY, I RELAPSED AND WAS HOSPITALIZED AGAIN FOR THE SAME SYMPTOMS AND THE NEW ONSET OF ELECTRICAL SHOCK SENSATIONS AFFECTING THE RIGHT FACE. I REC'D A DIAGNOSIS OF MULTIPLE SCLEROSIS AND WAS STARTED ON HIGH-DOSE STEROIDS WITH A THREE WEEK TAPER AFTER DISCHARGE. A COUPLE OF WEEKS AFTER DISCHARGE IN (B)(6), WHILE TAPERING OFF STEROIDS, I DEVELOPED SPASMS IN THE RIGHT FACE. FACIAL REHABILITATION PARTIALLY RESOLVED THE PROBLEM. AT MY CLINIC F/U IN NEUROLOGY, THERE WAS TALK OF AUTOIMMUNE DISEASE AND PLASMAPHERESIS WHICH WAS NEVER PERFORMED DUE TO IMPROVEMENT IN MY CLINICAL CONDITION. AT THE FOLLOWING CLINIC VISIT, THE DIAGNOSIS OF ADEM WAS SUGGESTED AND THIS HAS REMAINED THE WORKING DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366818 SURGICAL CO2 LASER LASER EWG LUTRONIC CE 0434

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S