BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CANAL BRUSH

    MDR report key: 2200979 · Received July 1, 2011

    Report

    Report Number
    2648666-2011-00165
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CLEANING THE BRUSHES IN PREPARATION FOR SURGERY, THE FEMORAL CANAL BRUSH BRISTLES HAD BROKEN OFF OR WERE MISSING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL BRUSH FQH STRYKER INSTRUMENTS PUERTO RICO 10219012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK