BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL CANAL BRUSH

    MDR report key: 1202948 · Received October 16, 2008

    Report

    Report Number
    2648666-2008-00124
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT BACK TO THE MFR, BUT THE INVESTIGATION HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE WASHING OUT IN THE INTRASPINE SOME OF THE FIBERS FROM THE FEMORAL CANAL BRUSH CAME OFF. THE SURGEON LAVAGED OUT THE FIBERS, BUT COULD NOT CONFIRM THAT ALL WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL BRUSH LAVAGE, JET FQH STRYKER INSTRUMENTS PUERTO RICO 08159012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention