BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTABLE MONOPOLAR EMG NEEDLE ELECTRODE

    MDR report key: 4006274 · Received August 7, 2014

    Report

    Report Number
    MW5037717
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 6, 2014
    Manufacturer
    CHALGREN ENTERPRISES INC
    Product Code
    IKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING BOTOX INJECTION USING CHALGREN ENTERPRISES DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE, THE ELECTRODE NEEDLE BROKE OFF AT THE HUB AND WAS RETAINED IN THE PT'S ADIPOSE TISSUE. CONFIRMED WITH X-RAY. DECISION WAS MADE TO LEAVE INTACT VERSUS ATTEMPTING TO REMOVE AFTER CONSULTATION WITH ORTHO AND GENERAL SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465873 INJECTABLE MONOPOLAR EMG NEEDLE ELECTRODE NEEDLE ELECTRODE IKT CHALGREN ENTERPRISES INC 242-025-24TP 257

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR