BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 3503984 · Received November 25, 2013

    Report

    Report Number
    1055581-2013-00004
    Event Type
    Injury
    Date Received
    November 25, 2013
    Date of Event
    October 18, 2013
    Report Date
    October 30, 2013
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AFTER PATIENT REPORTEDLY DEVELOPED A 2ND DEGREE BURN WITH BLISTERS APPROXIMATELY 1/2 X 1/2" AND A REDDENED AREA APPROXIMATELY 5CM X 2CM ON THE LE CALF FOLLOWING TREATMENT WITH AN ANODYNE THERAPY PROFESSIONAL SYSTEM. PATIENT SELF ADMINISTERED SILVADENE, AND DID RECEIVE MEDICAL INTERVENTION OF A TOPICAL ANTIBIOTIC. REPORTED TREATMENT TIME AND INTENSITY WAS WITHIN THE GUIDELINES PROVIDED TO THE USER IN THE IFU MANUAL. EVALUATION IDENTIFIED A BROKEN WIRE IN ONE THERAPY PAD, AND A BAD CONNECTION IN ONE JACK, NEITHER OF WHICH WOULD BE EXPECTED TO CAUSE HIGH TEMPERATURES. ADDITIONALLY, DURING SIMULATED USE, THE THERAPY PAD TEMPERATURES WERE FOUND TO BE WELL WITHIN LEVELS THAT WOULD NOT BE EXPECTED TO CAUSE A BURN. THE FACILITY REPORTED THAT THEY USED THIS SAME ANODYNE UNIT ON VARIOUS OTHER PATIENTS AROUND THE SAME TIME AS THE REPORTED INJURY WITHOUT INCIDENT. ACCORDINGLY, ANODYNE IS NOT ABLE TO CONFIRM THAT THIS ANODYNE UNIT CAUSED THE REPORTED INJURY. 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 THIS TYPE.

    Description of Event or Problem · 1

    TREATING FACILITY REPORTS A PATIENT DEVELOPED A BURN WITH BLISTERS APPROXIMATELY 1/2" X 1/2" AND A REDDENED AREA 5CM X 2CM ON THE CALF FOLLOWING AN ANODYNE THERAPY TREATMENT. REPORTED PATIENT INJURY HAS COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611505 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention