BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 858637 · Received May 31, 2007

    Report

    Report Number
    1055581-2007-00008
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 31, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TREATING FACILITY REPORTED THAT THIS PATIENT HAD BEEN TREATED FOR 45 MINUTES AT AN ENERGY SETTING OF 10 WHICH EXCEEDS THE GUIDELINE PROVIDED IN THE IMPORTANT SAFETY AND INFORMATION MANUAL PROVIDED TO THE FACILITY. FACILITY HAS BEEN RETRAINED ON THE PROPER USE OF THE SYSTEM. WE HAVE REQUESTED THAT THIS UNIT BE RETURNED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. 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 PATIENTS AND CLINICIANS TO HEED THE WARNINGS AND TO FOLLOW THE ADEQUATE DIRECTIONS FOR USE THAT ACCOMPANY THE DEVICE.

    Description of Event or Problem · 1

    PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE CALF, APPROXIMATELY 1/4" X 1/4", FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. THE PATIENT HAS BEEN TREATED WITH SILVADENE, AND HAS HEALED.

    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 YR Required Intervention