BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 745650 · Received July 11, 2006

    Report

    Report Number
    MW1039651
    Event Type
    Injury
    Date Received
    July 11, 2006
    Date of Event
    April 14, 2006
    Report Date
    July 11, 2006
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANODYNE THERAPY DEVICE WAS APPLIED TO THE GROIN AREA TO TREAT THE CONDITION SHINGLES, BY A PHYSICAL THERAPIST. THE THERAPIST WAS NOT INSTRUCTED OR HAD NO KNOWLEDGE HOW TO USE THIS BEFORE IT WAS APPLIED. AS A RESULT, SERIOUS BURNS, SWELLING, AND PAIN WERE RECEIVED BY THE PT IN THE GROIN, BUTTOCK, HIPS. PT REPORTED THE BURN INCIDENTS TO ANODYNE THERAPY SEVERAL TIMES, AND WAS MET WITH INDIFFERENCE AND NO ONE RETURNED THE CALL. THE PHYSICAL THERAPIST EVENTUALLY EMAILED ANODYNE THERAPY SEVERAL TIMES, AND ANODYNE SENT A LETTER CLAIMING INDIFFERENCE AND NO RESPONSIBILITY. ANODYNE STILL HAS NEVER CALLED THE PT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY ANODYNE INFRARED THERAPY ILY ANODYNE THERAPY, LLC PROFESSIONAL MODEL *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S