BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QORA AIM STOOL MANAGEMENT KIT

    MDR report key: 12173427 · Received July 15, 2021

    Report

    Report Number
    12173427
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 25, 2021
    Manufacturer
    CM TECHNOLOGIES, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE QORA FECAL MANAGEMENT SYSTEM DEVICE WAS REMOVED FROM THE PATIENT'S RECTUM DUE TO DECREASE IN FREQUENCY OF BOWEL MOVEMENT AND CHANGE IN CONSISTENCY OF BOWEL MOVEMENT. THE RELEASE TAG WAS PULLED, HOWEVER , IT FELT AS THOUGH THE SPRINGS INSIDE THE PATIENT THAT HELD THE QORA IN, DID NOT FULLY COMPRESS. MULTIPLE ATTEMPTS WERE MADE TO RETRACT THE SPRING WITH THE PULL TAG, BUT IT MADE NO CHANGE. ONCE THE QORA WAS THEN PULLED OUT, THE PATIENT STARTED EXPERIENCING BRIGHT RED BLEEDING FROM THE RECTUM IN A SMALL AMOUNT AND THE DEVICE APPEARED THAT IT HAD NOT COMPRESSED ALL OF THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069257 QORA AIM STOOL MANAGEMENT KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CM TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Other