BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 1214726 · Received October 27, 2008

    Report

    Report Number
    1055581-2008-00014
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    March 15, 2006
    Report Date
    October 24, 2008
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON TOP OF THE RIGHT FOOT FOLLOWING TREATMENT ON THE TOP AND BOTTOM OF FEET FOR 40 MINUTES. PRODUCT SAFETY AND INFORMATION MANUAL CLEARLY STATES TO TREAT FOR INCREASED CIRCULATION WITH PADS PLACED ON THE BOTTOM OF THE FOOT AND THE CALVES. THE UNIT WAS RETURNED FOR EVAL AND FOUND TO BE WITHIN OPERATING SPECIFICATIONS. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENT REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS TYPE. THIS ADVERSE EVENT IS BEING REPORTED AT THIS TIME, AS A RESULT OF A CHANGE TO THE COMPANY DECISION TREE FOR REPORTABLE EVENTS.

    Description of Event or Problem · 1

    PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE TOP OF THE FOOT FOLLOWING TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. PATIENT DID NOT RECEIVE MEDICAL INTERVENTION AND HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY INTRARED LAMP ILY ANODYNE THERAPY, LLC 120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other