BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 846245 · Received May 1, 2007

    Report

    Report Number
    1055581-2007-00007
    Event Type
    Injury
    Date Received
    May 1, 2007
    Date of Event
    March 29, 2007
    Report Date
    April 30, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER REPORTED THAT THEY DID NOT OPERATE THE UNIT IN ACCORDANCE WITH SAFETY GUIDELINES. THE SAFETY AND INFORMATION MANUAL PROVIDED WITH EACH UNIT CAUTIONS USERS NOT TO SLEEP WITH THE THERAPY PADS TURNED ON, AS THIS MAY CAUSE BURNS. USER FELL ASLEEP WITH THE UNIT TUNRED ON, AND REALIZED HIS ERROR. CUSTOMER REPORTED HE HAD USED THE SYSTEM MULTIPLE TIMES PREVIOUSLY, ALL WITHOUT INCIDENT. THE UNIT INVOLVED IN THIS EVENT HAS BEEN RETURNED FOR EVALUATION, AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS AN TEMPERATURE GUIDELINES. 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 PATIENT'S 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 AFTER FALLING ASLEEP DURING TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. THE BURN MEASURED APPROXIMATELY 1 1/4" IN DIAMETER AND WAS LOCATED ON THE BACK OF THE LEG JUST ABOVE THE ANKLE. THE PATIENT HAS RECEIVED MEDICAL INTERVENTION, BEING TREATED WITH ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention