BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY

    MDR report key: 776479 · Received August 25, 2006

    Report

    Report Number
    1055581-2006-00033
    Event Type
    Malfunction
    Date Received
    August 25, 2006
    Date of Event
    July 28, 2006
    Report Date
    August 25, 2006
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VOLTAGE AND FREQUENCY WERE TESTED, AND READINGS VERIFIED THE UNIT WAS OPERATING WITHIN SPECIFICATIONS. A FREE AIR TEST WAS CONDUCTED ON THE ARRAY THAT EXHIBITED A BRIGHT ROW OF LED'S, AND TEMPERATURE WERE FOUND TO EXCEED GUIDELINES. A SMALL SOLDER BALL WAS FOUND LODGED UNDER AND BRIDGING A CHIP RESISTOR. THIS ALLOWED A HIGHER CURRENT FLOW TO THE LED'S, RESULTING IN HIGHER TEMPERATURE READINGS ON THE ARRAY. 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 THIS MDR. WE BELIEVE THIS TO BE AN ISOLATED EVENT, AND WILL MONITOR FOR ANY FUTURE TRENDS.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT A ROW OF LED'S ON ONE THERAPY PAD WERE VERY BRIGHT, AND THAT THE UNIT WAS GETTING WARM.

    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 * Other