BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 1214722 · Received October 27, 2008

    Report

    Report Number
    1055581-2008-00008
    Event Type
    Injury
    Date Received
    October 27, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ABOVE THE ANKLE FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM FOR 30 MINUTES AT AN ENERGY SETTING OF 7. THIS IS WITHIN THE TREATMENT GUIDELINES PROVIDED IN THE IMPORTANT SAFETY AND INFORMATIONAL MANUAL. THE UNIT WAS RETURNED FOR EVAL, AND FOUND TO BE OPERATING WITHIN TEMPERATURE SPECIFICATIONS. A BROKEN BLACK WIRE WAS IDENTIFIED, BUT WOULD NOT HAVE CAUSED THE EVENT. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THE NATURE. 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 ABOVE HIS ANKLE FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, APPLIED BY A HEALTH CARE PROFESSIONAL. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO DETERMINE INFO RELATIVE TO THE SIZE, DATE OF THE EVENT, AGE OF THE PT, AND DATE OF 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 Other