BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURO TRACE

    MDR report key: 2596223 · Received May 24, 2012

    Report

    Report Number
    2925153-2012-00001
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 23, 2012
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    BXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. FOLLOW UP WILL BE PROVIDED AS ADDITIONAL INFORMATION IS RECEIVED AND COMPLAINT INVESTIGATION ANALYSIS ((B)(4)) IS COMPLETED PENDING DEVICE BEING RETURNED BY END USER.

    Description of Event or Problem · 1

    NEURO TRACE NEEDLE REPORTED BY END USER TO HAVE A HOLE BETWEEN NEEDLE AND EXTENSION. AIR GOING THROUGH WHERE THE HUB AND EXTENSION MEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO TRACE NEURO TRACE NEEDLE BXN NEO MEDICAL, INC. 553-22-07 0163

    Patients

    Seq Age Sex Outcome Treatment
    1