BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL CANAL BRUSH

    MDR report key: 1131916 · Received August 20, 2008

    Report

    Report Number
    2648666-2008-00089
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 20, 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 BRUSH WAS RETURNED TO THE MANUFACTURER, AND THE ALLEGED CONDITION WAS CONFIRMED. THE BATCH RECORDS WERE REVIEWED AND FOUND TO BE SATISFACTORY. THE FUNCTIONAL USE OF THIS DEVICE DOES ALLOW FOR EXCESSIVE HANDLING IN ORDER TO CLEAN THE AFFECTED AREA. IF THERE IS AN INCREASE IN FORCE OR FRICTION, IT IS POSSIBLE THAT THE FIBERS MAY BECOME SLIGHTLY DAMAGED AND FALL OFF DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE WASHING OUT THE INTRASPINE SOME OF THE FIBERS FROM THE FEMORAL CANAL BRUSH CAME OFF. THE FIBERS WERE RINSED OUT WITH WATER PRESSURE BUT THE SURGEON COULD NOT CONFIRM THAT ALL WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL BRUSH LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 08075012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention