BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1190184 · Received October 3, 2008

    Report

    Report Number
    1190184
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 14, 2008
    Report Date
    October 3, 2008
    Manufacturer
    GRASS TECHNOLOGIES
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SET UP ON EEG LONG TERM MONITORING ON FRIDAY WITH A COMPLETE HEAD SET INCLUDING TWO SPHENOIDAL NEEDLE ELECTRODES. (THEY ARE PLACED JUST FORWARD OF THE PIVOT OF THE LOWER JAWBONE AND ARE CEMENTED IN PLACE USING GAUZE AND COLLODION). THE PATIENT WENT HOME THAT DAY AND RETURNED ON SUNDAY TO HAVE EVERYTHING REMOVED FROM HER HEAD. SHE COMPLAINED TO THE EEG TECH THAT SHE HAS BEEN IN PAIN FROM THE LEFT NEEDLE ELECTRODE SINCE THEY PUT THE NEEDLE ELECTRODE IN. USING ACETONE, HE REMOVED THE GAUZE COVERING FROM THE ELECTRODE AND THE HUB AND WIRE FELL TO THE FLOOR. THERE WAS NO NEEDLE ATTACHED TO IT. SOMEBODY LOOKED AROUND AND COULDN'T FIND THE NEEDLE PORTION. SHE SUBSEQUENTLY REQUIRED A BRIEF SURGICAL PROCEDURE IN ORDER TO HAVE THE NEEDLE REMOVED AND WAS DISCHARGED FROM THE PACU. NOTED THAT SHARP TIP OF NEEDLE WAS CURLED, THAT NEEDLE IS NORMALLY AT 105° BUT WAS BENT ABOUT 25° TO 80° AND THEN FRACTURED.====================== MANUFACTURER RESPONSE FOR ELECTRODE, NEEDLE, SUBDERMAL ======================THIS HAS NEVER HAPPENED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ELECTRODE, NEEDLE,SUBDERMAL GXY GRASS TECHNOLOGIES * AUGUST 2008

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR NO OTHER THERAPIES| NO OTHER THERAPIES