BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOPERSURGICAL, INC

    MDR report key: 4068395 · Received September 4, 2014

    Report

    Report Number
    MW5038086
    Event Type
    Other
    Date Received
    September 4, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COOPERSURGICAL, INC
    Product Code
    LKF
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BALLOON BURST. A PORTION OF BALLOON CAME IN CONTACT WITH THE PELVIC CAVITY, BUT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539790 COOPERSURGICAL, INC UTERINE MANIPULATOR LKF COOPERSURGICAL, INC MANIPULATOR UT 5.1MM RUMI 6CM

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR