BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITUS MEDICAL (UTERINE MANIPULATOR INJECTOR)

    MDR report key: 22161446 · Received June 6, 2025

    Report

    Report Number
    MW5171160
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 30, 2025
    Manufacturer
    TITUS MEDICAL LLC
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TITUS MEDICAL (UTERINE MANIPULATOR INJECTOR) TMI1151-S LOT: A240313 BROKE INTO PIECES DURING PROCEDURE. HYSTEROSCOPY COMPLETED TO VERIFY NO RETAINED PIECES. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265261 TITUS MEDICAL (UTERINE MANIPULATOR INJECTOR) CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF TITUS MEDICAL LLC A240313

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other