BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA

    MDR report key: 21574752 · Received March 11, 2025

    Report

    Report Number
    3013524793-2024-00001
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    April 8, 2024
    Manufacturer
    CM TECHNOLOGIES INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION MADE AVAILABLE BY THE USER FACILITY THE EVENT IS CLASSIFIED AS A SERIOUS INJURY. WITHIN THE COMPLAINT INITIATED FOR THIS EVENT A DETAILED INVESTIGATION OF RETAINED SAMPLES WAS CONDUCTED. THE RESULTS INDICATE THAT THE DEVICE COULD NOT CAUSE OF SERIOUS INJURY. NO ADDITIONAL INFORMATION IS MADE AVAILABLE BY THE USER FACILITY. THIS MATTER WILL BE CONTINUOUSLY MONITORED AND ANALYSED VIA POST MARKET SURVEILLANCE FOR CONTINUAL DEVICE SAFETY AND FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY USER FACILITY THAT "THEY HAVE SEEN AN INCREASED IN RECTAL BLEEDING IN PATIENTS THAT DID NOT HAVE BLEEDING PRIOR TO THE INITIATION OF THE FECAL MANAGEMENT SYSTEM. RECENTLY, ONE OF OUR ICU NURSES WAS ASKED TO ASSIST A NURSE ON THE FLOOR TAKE ONE OUT DUE TO BLEEDING. WHEN SHE APPEARED IN THE ROOM, THERE WAS FRANK BLEEDING AND CLOTS COMING FROM THE RECTUM. THE PATIENT WAS TRANSFERRED TO THE ICU TO BE GIVEN MASSIVE AMOUNTS OF BLOOD PRODUCTS. IN SPEAKING WITH GI PHYSICIANS, THEY ARE SEEING AN INCREASED NUMBER IN PATIENTS DURING COLONOSCOPY HAVE TRIANGULAR SHAPED ULCERATIONS IN THEIR RECTUM, WHICH MATCHED THE OPENING OF THIS PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335590 QORA STOOL MANAGEMENT SYSTEM KNT CM TECHNOLOGIES INC. MG-22014-002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization