BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP KERRISON RONGEUR WITH A THIN FOOTPLATE

    MDR report key: 18886019 · Received March 12, 2024

    Report

    Report Number
    18886019
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    November 7, 2023
    Report Date
    November 8, 2023
    Manufacturer
    AESCULAP, INC.
    Product Code
    KBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    KERRISON THAT HAD BEEN PLACED ON STAND WAS FOUND TO HAVE MISSING SCREW DURING CASE. SCREW WAS NOT FOUND DURING VISUAL SEARCH. X-RAY WAS TAKEN AND READ BY RADIOLOGIST WHO CONFIRMED THERE WAS NO RETAINED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716958 AESCULAP KERRISON RONGEUR WITH A THIN FOOTPLATE RONGEUR, NASAL KBB AESCULAP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male