BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX

    MDR report key: 2913335 · Received November 2, 2012

    Report

    Report Number
    2913335
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 1, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    A NEEDLE BROKE OFF IN PATIENT'S LOWER SPINE DURING A LUMBAR PUNCTURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRASONIC COAGULATION DEVICE LFL COVIDIEN * N2E0031X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR