BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROID

    MDR report key: 886687 · Received July 26, 2007

    Report

    Report Number
    3004444071-2007-00001
    Event Type
    Other
    Date Received
    July 26, 2007
    Date of Event
    May 9, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ECLOSION KFT
    Product Code
    HCC
    PMA / PMN Number
    K892114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSIGNIFICANT RISK OF SKIN IRRITATION IS DUE TO INAPPROPRIATE USE OF THE HARNESSES. THIS FURTHER PROMPTED US TO CHANGE THE LABELING TO SHOW A CLEAR WARNING. THE LABELING HAS BEEN CHANGED TO WARN USERS NOT TO PLACE THE HARNESS CONNECTORS AGAINST THE SKIN.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL WAS USING THE DEVICE ON HERSELF. SHE USED THE DEVICE INCORRECTLY IN THAT SHE PLACED THE HARNESS LEAD CONNECTORS AGAINST HER SKIN. SHE HAD AN ALLERGIC REACTION WHICH CAUSED INFLAMMATION THAT LED TO SKIN URTICARIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROID BIOFEEDBACK DEVICE HCC ECLOSION KFT

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other