BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE

    MDR report key: 752438 · Received May 9, 2005

    Report

    Report Number
    MW1035442
    Event Type
    Injury
    Date Received
    May 9, 2005
    Date of Event
    May 5, 2005
    Report Date
    May 9, 2005
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANODYNE THERAPY IS CLAIMED BY THE MANUFACTURER TO REDUCE THE NUMBNESS AND PAIN OF PERIPHERAL NEUROPATHY, A CONDITION I HAVE. I HAD A TREATMENT WHICH WAS ADMINISTERED AT AN AUTHORIZED ANODYNE THERAPY CENTER AND HAD A HORRIBLE REACTION, NAMELY A SEVERE WORSENING OF MY CONDITION WHICH MAY BE IRREVERSIBLE. I ALSO NOW HAVE SEVERE BACK PAIN WHICH I DID NOT HAVE WHEN I WENT THERE. I DON'T HAVE A BACK PROBLEM, AT LEAST I DIDN'T WHEN I WENT THERE. I HAD BEEN TOLD THAT WORST CASE REACTION WAS THAT THE THERAPY WOULD DO NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE LEG & ARM "BANDS" WITH INFRARED DIODES ILY ANODYNE THERAPY, LLC 480 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| S