BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA AEON

    MDR report key: 21574743 · Received March 11, 2025

    Report

    Report Number
    3013524793-2021-00002
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    June 21, 2021
    Manufacturer
    CM TECHNOLOGIES INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    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. A COMPLAINT HAS BEEN INITIATED AND INVESTIGATION CONDUCTED. THE INVESTIGATION CONCLUDES THAT THE ISSUE RESULTED FROM INCORRECT DEVICE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A PATIENT HAD DEVELOP A SEVERE RECTAL BLEED AND THE DEVICE WAS SLIPPED OUT OF RECTUM OF THE PATIENT. IMMEDIATELY THE PATIENT SUFFERED FROM A SUDDEN DROP IN HEMOGLOBIN AND HEMATOCRIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335581 QORA AEON STOOL MANAGEMENT SYSTEM KNT CM TECHNOLOGIES INC. MG-12015-003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization