BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA

    MDR report key: 24793941 · Received April 6, 2026

    Report

    Report Number
    MW5186385
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CONSURE MEDICAL/ CM TECHNOLOGIES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    QORA FMS ORDERED ON (B)(6) 2026. ON (B)(6) 2026 PATIENT DEVELOPED SIGNIFICANT RECTAL BLEEDING AND A DROP IN HEMOGLOBIN. PATIENT WITH HISTORY OF LIVER DYSFUNCTION AND ETOH (ETHANOL). INVESTIGATION BY SUBJECT MATTER EXPERTS RESULTED THAT THE BLEEDING WAS ATTRIBUTED TO THE QORA FMS AND HAS THUS BEEN REMOVED FROM USE IN OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848138 QORA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONSURE MEDICAL/ CM TECHNOLOGIES, INC. MG-22014-002 132412

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention