BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONNER MANIPULATOR

    MDR report key: 8088857 · Received November 20, 2018

    Report

    Report Number
    8088857
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 29, 2018
    Report Date
    November 14, 2018
    Manufacturer
    KRONNER PROTOTYPES, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KRONNER UTERINE MANIPULATOR (TWO DIFFERENT LOT NUMBERS) BEING USED FOR ABDOMINAL MYOMECTOMY. THE BALLOON FAILED ON DEVICE NUMBER ONE AND DEVICE NUMBER TWO. A THIRD DEVICE WAS USED WITHOUT INCIDENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928236 KRONNER MANIPULATOR CANNULA, MANIPULATOR/INJECTOR LKF KRONNER PROTOTYPES, INC. 6003 243579, 243574

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA