BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 841739 · Received April 19, 2007

    Report

    Report Number
    1055581-2007-00006
    Event Type
    Injury
    Date Received
    April 19, 2007
    Date of Event
    March 25, 2007
    Report Date
    April 19, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TREATING FACILITY REPORTED THAT THIS PATIENT WAS BEING TREATED BY A RELIEF NURSE WHO THEY REPORTED HAD NOT OPERATED THE UNIT IN ACCORDANCE WITH SAFETY GUIDELINES. SHE HAD TREATED THIS PATIENT'S CONDITION FOR 45 MINUTES AT AN ENERGY SETTING OF 10 WHICH EXCEEDS THE GUIDELINE PROVIDED IN THE IMPORTANT SAFETY AND INFORMATION MANUAL PROVIDED WITH EACH UNIT. WE HAVE REQUESTED THAT THE CUSTOMER RETURN THE UNIT TO US FOR EVALUATION, BUT IT 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

    PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE KNUCKLE OF THE 1ST FINGER OF THE LEFT HAND AND ANOTHER JUST BELOW HER KNEE. THIS OCCURRED FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PT WAS TREATED WITH TRIPLE ABX AND SILVADENE AND HAS HEALED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention