BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR

    MDR report key: 19449127 · Received May 31, 2024

    Report

    Report Number
    MW5155678
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 28, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BIOTEQUE AMERICA, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TEAM HAS REPORTED THAT THE UTERINE MANIPULATORS FROM BIOTEQUE AMERICA HAVE BEEN MALFUNCTIONING. THE BALLOON AT THE END WILL NOT DEFLATE. I DO NOT HAVE ANY SPECIFIC PATIENTS THIS HAPPENED ON, A TECH BROUGHT IT TO MY ATTENTION AND GAVE ME ONE THAT HAD BEEN OPENED BUT NOT USED. BIOTEQUE AMERICA, SKU#: UMI4.5K, LOT: A221004, EXP: 2025-09-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149830 UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF BIOTEQUE AMERICA, INC. UMI4.5K A221004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other