BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE

    MDR report key: 2225562 · Received August 23, 2011

    Report

    Report Number
    2225562
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 23, 2011
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Product Code
    IKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE EMG NEEDLE SEPARATED AT THE HUB. C-ARM X-RAY WAS OBTAINED AND SHOWED POSITION OF NEEDLE TO BE APPROXIMATELY 1 1/2 INCHES IN DEPTH FROM SURFACE OF POSTERIOR LEG. CONSULTED GENERAL SURGERY AND MD DISCUSSED OPTIONS OF LEAVING NEEDLE IN PLACE VERSUS SURGICAL REMOVAL. HE FELT THAT IT IS A STERILE FOREIGN BODY AND AS SHE IS NOT AMBULATORY THAT SHE MAY BE ASYMPTOMATIC. HE DISCUSSED SURGICAL INTERVENTION IN THE MAIN OR. HE FELT IT COULD BE DIFFICULT TO LOCATE BECAUSE OF ITS SMALL SIZE. PARENT HAD AN OPPORTUNITY TO ASK QUESTIONS AND THEY WERE ANSWERED. AT THIS TIME PARENT HAS DECIDED TO NOT HAVE SURGICAL INTERVENTION AND WAIT AND SEE HOW SHE DOES. SHE KNOWS THAT PT MAY BE SEEN IN PHYSICAL MEDICINE & REHABILITATION (PMR) CLINIC OR GENERAL SURGERY CLINIC FOR FURTHER EVALUATION AS NEEDED. IN THE FUTURE SHE MAY HAVE SURGICAL INTERVENTION IF PATIENT'S MOTHER WOULD LIKE OR FOR ANY COMPLICATIONS/SYMPTOMS FROM THE FOREIGN BODY. BASE LINE X-RAY WAS OBTAINED TODAY. PATIENT'S MOTHER COUNSELED TO MONITOR FOR SWELLING, REDNESS OR WARMTH AT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH IKT CHALGREN ENTERPRISES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR