BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 3313383 · Received August 20, 2013

    Report

    Report Number
    1055581-2013-00003
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVAL AFTER PT REPORTEDLY DEVELOPED A 2ND DEGREE BURN THE SIZE OF A QUARTER ON THE RT CALF FOLLOWING TREATMENT WITH AN ANODYNE THERAPY PROFESSIONAL SYSTEM. PT DID RECEIVED MEDICAL INTERVENTION - A TOPICAL ANTIBIOTIC. REPORTED TREATMENT TIME AND INTENSITY WAS WITHIN THE GUIDELINES PROVIDED TO THE USER IN THE IFU MANUAL. UPON EVAL, A DEFECTIVE TRANSISTOR WAS IDENTIFIED; HOWEVER, THERAPY PAD TEMPERATURES DURING SIMULATED USE WERE FOUND TO BE WILL WITHIN LEVELS THAT WOULD NOT BE EXPECTED TO CAUSE A BURN. ADDITIONALLY, THE FACILITY REPORTED THEY USED THIS SAME ANODYNE UNIT ON OTHER PTS WITHOUT INCIDENT AROUND THE SAME TIME AS THE REPORTED INJURY. 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 PT DEVELOPED A BURN THE SIZE OF A QUARTER ON THE CALF FOLLOWING AN ANODYNE THERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403864 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention