BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROGENX 4000PRO

    MDR report key: 3926562 · Received July 7, 2014

    Report

    Report Number
    MW5037096
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    May 13, 2014
    Report Date
    July 4, 2014
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS TREATED BY A PODIATRIST FOR CIDP (A TYPE OF PERIPHERAL NEUROPATHY) WITH A NEUROGENX 4000 PRO. THE STEM PART OF THE TREATMENT HAS RESULTED IN A BAD CASE OF CHRONIC TENDONITIS ON THE INSTEP OF MY LEFT FOOT. I INITIALLY HAD A PROBLEM WITH THIS CONDITION ON BOTH FEET AFTER THE TREATMENT. I COMPLAINED TO DR (B)(6), AND HE PRESCRIBED NAPROZEN 500MG 2X/DAY. HOWEVER, I HAVE FINISHED THE COURSE OF TREATMENT AND STILL HAVE CONSIDERABLE DISCOMFORT. I SURE HOPE THE INJURY IS NOT GOING TO BE PERMANENT. I AM USING ICE AND IBUPROFEN, BUT I AM AWAKING IN THE MIDDLE OF THE NIGHT WITH AN INTENSE PAIN/SPASM AT MY INSTEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393217 NEUROGENX 4000PRO NEUROGENX 4000PRO GZI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability