BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRONNER MANIPU-JECTOR UTERINE

    MDR report key: 3080399 · Received April 23, 2013

    Report

    Report Number
    MW5029932
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COOPER SURGICAL INC
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON INSERTED KRONNER MANIPU-JECTOR, MANIPULATOR-INJECTOR. UNABLE TO DEFLATE BALLOON WITH SYRINGE. TUBING WAS CUT BY SURGEON; BALLOON WOULD NOT DEFLATE. SURGEON REMOVED THE DEVICE FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174520 KRONNER MANIPU-JECTOR UTERINE MANIPULATOR LKF COOPER SURGICAL INC 6003 130118

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention