BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC MST KIT

    MDR report key: 2222515 · Received July 13, 2011

    Report

    Report Number
    2925153-2011-00008
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 6, 2011
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WILL PROVIDE F/U "DEVICE EVAL SUMMARY" IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    WING CAME OFF BEFORE IT WAS SUPPOSED TO, BEFORE IT DID WHAT IT WAS INTENDED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMAGIC MST KIT MST KIT LJS NEO MEDICAL, INC. 1958-004 1005

    Patients

    Seq Age Sex Outcome Treatment
    1