BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-UMIL-050037; UMI-LOC LOCKABLE UTERINE MANIPULATOR INJECTOR

    MDR report key: 5006560 · Received August 7, 2015

    Report

    Report Number
    1833117-2015-00004
    Event Type
    Injury
    Date Received
    August 7, 2015
    Report Date
    August 5, 2015
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    PMA / PMN Number
    K974357
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED, 5 UNUSED DEVICES FROM THE SAME LOT WAS RETURNED. THE EVALUATION (BOTH VISUAL AND FUNCTIONAL) OF THE RETURNED UNITS SHOWS NO DEFECT FROM THE DEVICE THAT COULD CONTRIBUTE TO THE PERFORATION OF THE UTERUS DURING INSERTION.

    Description of Event or Problem · 1

    ON INSERTION OF THE PRODUCT, THE UTERUS WAS PERFORATED. THIS HAPPENS ON 3 DIFFERENT OCCASIONS INVOLVING 2 DIFFERENT OPERATORS. A 10 ML LAPAROSCOPE AND GYNAE LAP INSTRUMENTS ALSO USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521390 J-UMIL-050037; UMI-LOC LOCKABLE UTERINE MANIPULATOR INJECTOR UTERINE MANIPULATOR/INJECTOR LKF CATHETER RESEARCH, INC. UMI-LOC K273

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention