BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 1656396 · Received April 6, 2010

    Report

    Report Number
    MW5015478
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    October 9, 2009
    Report Date
    April 6, 2010
    Manufacturer
    ANODYNE THERAPY
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS USING ANODYNE THERAPY 3 TIMES A WEEK FOR 45 MINUTES PER SESSION. THERAPY SESSIONS WERE CONDUCTED WITHIN RECOMMENDED GUIDELINES. NOTHING OUT OF THE ORDINARY IN REGARDS TO THE WAY ANODYNE THERAPY WAS ADMINISTERED. WITHIN TWO MONTHS OF THERAPY, A LARGE BLISTER DEVELOPED ON THE RIGHT LEG, AND IT TURNED OUT TO BE A 3RD DEGREE BURN. ALL LITERATURE I'VE FOUND ON THE INTERNET INCLUDING SAFETY TIPS PROVIDED ON ANODYNE COMPANY WEBSITE STATED THAT THE WORST SIDE EFFECTS THAT COULD RESULT FROM ANODYNE THERAPY WAS MILD, SUPERFICIAL BURNS. THIRD DEGREE BURN THAT RESULTED FROM ANODYNE THERAPY, - MODEL 480 - HAS TAKEN OVER 6 MONTHS TO HEAL AND IS STILL IN THE LAST STAGES OF HEALING AND MAY TAKE 6 MONTHS OR LONGER TO BECOME MORE SOLIDLY HEALED. I AM A DIABETIC AND WAS USING ANODYNE TO HELP SPEED THE HEALING OF A DIABETIC FOOT ULCER, -RIGHT FOOT-. END RESULT IS THAT I HAVE HAD TO CARE FOR TWO ULCERS AS WELL AS PAY ADDITIONAL OUT OF POCKET EXPENSES TO HAVE 3RD DEGREE BURN ASSESSED BY DOCTORS AND TREATED ON A DAILY BASIS TO PREVENT LIFE THREATENING INFECTION AND PREVENT FURTHER, WORSE COMPLICATIONS. FREQUENCY: 3 TIMES A WEEK FOR 45 MINUTES. ROUTE: OTHER. DATES OF USE: (B) (6) 2009 - (B) (6) 2009, 45 MINUTES PER SESSION. DIAGNOSIS OR REASON FOR USE: TO SPEED HEALING OF DIABETIC FOOT ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY ANODYNE INFRARED THERAPY PRODUCTS, 780 MW, WAVELENGTH - 890 ILY ANODYNE THERAPY 480 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening