BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL CANAL BRUSH

    MDR report key: 1131917 · Received August 20, 2008

    Report

    Report Number
    2648666-2008-00088
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 22, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRUSH WAS RETURNED TO THE MANUFACTURER FOR INSPECTION, THE BROKEN FIBERS WERE CONFIRMED. THE BATCH RECORDS WERE REVIEW AND FOUND TO BE SATISFACTORY. THE FUNCTIONAL USE OF THIS PRODUCT DOES ALLOW FOR EXCESSIVE HANDLING TO CLEAN THE AFFECTED AREA OF THE PATIENT. WITH 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 SOME OF THE FIBERS OF THE FEMORAL CANAL BRUSH BROKE OFF DURING USE. THE BROKEN FIBRES WERE RINSED OUT AS MUCH AS POSSIBLE, BUT THERE IS A CHANCE THAT SOME MAY HAVE REMAINED IN THE FEMORAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL BRUSH LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 07237012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention