BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 19665806 · Received July 3, 2024

    Report

    Report Number
    19665806
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 11, 2024
    Manufacturer
    STRYKER CORPORATION
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER FEMORAL CANAL BRUSH (REF #0210-004-000). RUBBER O-RING IS BROKEN AND DETACHED FROM THE INSTRUMENT. RENDERS THIS UNUSABLE AND A DANGER TO THE PATIENT HAS THE BROKEN RUBBER PIECE FALLEN INTO THE PATIENT AND WE WERE UNAWARE OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757055 NA LAVAGE, JET FQH STRYKER CORPORATION 0210004000 22131012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown