BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE KOH COLPOTOMIZER SYSTEM

    MDR report key: 3952631 · Received July 18, 2014

    Report

    Report Number
    MW5037350
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 17, 2014
    Manufacturer
    COOPER MEDICAL
    Product Code
    HEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF FOUL SMELLING VAGINAL DISCHARGE 4 MONTHS POST ROBOTIC ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE RUMI SYSTEM AND COLPOPNEUMO OCCLUDER SYSTEM WAS USED AND THE PLASTIC KOH CUP WAS RETAINED IN VAGINA. THE KOH CUP WAS REMOVED IN THE CLINIC AT THE TIME OF DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423316 THE KOH COLPOTOMIZER SYSTEM COLPOTOMIZER SYSTEM HEX COOPER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention