BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURO TRACE II

    MDR report key: 2623683 · Received June 11, 2012

    Report

    Report Number
    2925153-2012-00003
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 8, 2012
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    FMI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. FOLLOW UP WILL BE PROVIDED AS ADD'L INFO IS RECEIVED AND COMPLAINT INVESTIGATION ANALYSIS (B)(4) IS COMPLETED.

    Description of Event or Problem · 1

    NEEDLE LEAKING WHERE LINE ATTACHES TO THE HUB. (ONE STERILE SAMPLE IS AVAILABLE FOR THIS LOT) THE USED PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO TRACE II NEURO TRACE NEEDLE FMI NEO MEDICAL, INC. 553-23-04 1204

    Patients

    Seq Age Sex Outcome Treatment
    1