BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTABLE MONOPOLAR NEEDLE ELECTRODE

    MDR report key: 3955743 · Received July 21, 2014

    Report

    Report Number
    MW5037373
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 18, 2014
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Product Code
    IKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING R POSTERIOR CERVICAL INJECTIONS WHEN EMG NEEDLE BROKE AT THE HUB AND WAS LODGED AND LOST BENEATH THE SKIN. AN ATTEMPT TO RETRIEVE THE NEEDLE WITH A SMALL INCISION UNDER LOCAL ANESTHETICS WAS UNSUCCESSFUL. THE BROKEN NEEDLE WAS RETRIEVED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426564 INJECTABLE MONOPOLAR NEEDLE ELECTRODE INJECTABLE MONOPOLAR NEEDLE ELECTRODE IKT CHALGREN ENTERPRISES, INC. 242-025-24TP X257

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R