BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 840067 · Received April 10, 2007

    Report

    Report Number
    1055581-2007-00005
    Event Type
    Injury
    Date Received
    April 10, 2007
    Date of Event
    March 9, 2007
    Report Date
    April 10, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT INVOLVED IN THIS EVENT HAS BEEN RETURNED FOR EVALUATION, AND WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS AND TEMPERATURE GUIDELINES. THE REPORTING FACILITY WAS TREATING THE PT FOR DIABETIC PERIPHERAL NEUROPATHY. THEY REPORTED TREATING THE PT AT AN ENERGY SETTING OF 10, WHICH EXCEEDS THE RECOMMENDED SETTING PROVIDED IN OUR IMPORTANT INSTRUCTION AND SAFETY MANUAL PROVIDED WITHOUT UNITS. THE PT HAD REC'D 12 PRIOR TREATMENTS WITH THE ANODYNE THERAPY SYSTEM, ALL WITHOUT INCIDENT. THE DESIGN AND FUNCTIONALITY OF ANODYNE'S DEVICE DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN OUR MDR'S. THE DIRECTIONS FOR USE AND WARNINGS THAT ACCOMPANY THE DEVICE ARE ADEQUATE FOR PURPOSES OF PREVENTING THERMAL INCIDENTS. WE BELIEVE THAT MOST OF THE REPORTED EVENTS HAVE RESULTED FROM THE ISOLATED FAILURE OF PTS AND CLINICIANS TO HEED THE WARNINGS AND TO FOLLOW THE ADEQUATE DIRECTIONS FOR USE THAT ACCOMPANY THE DEVICE.

    Description of Event or Problem · 1

    PT IS REPORTED TO HAVE DEVELOPED A BURN ON HIS RIGHT CALF, APPROXIMATELY 8 CM X 1 CM, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PT REC'D MEDICAL INTERVENTION AND WAS TREATED WITH LACTOFERRIN, AND IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention