BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA AEON

    MDR report key: 21574552 · Received March 11, 2025

    Report

    Report Number
    3013524793-2021-00001
    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

    THE EVENT IS CLASSIFIED AS A SERIOUS INJURY BASED ON THE AVAILABLE INFORMATION. A COMPLAINT HAS BEEN INITIATED AND INVESTIGATION CONDUCTED. BASED ON THE INFORMATION MADE AVAILABLE IT WAS CONCLUDED THAT THE ISSUE RESULTED FROM THE DEVICE USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A PATIENT HAD DEVELOP A SEVERE RECTAL BLEED DUE TO WHICH THE DEVICE WAS WITHDRAWN FROM THE PATIENT AS PER INSTRUCTION. A COLONOSCOPY WAS PERFORMED IMMEDIATELY, AND A SIGNIFICANT INTERNAL ULCERATION WAS OBSERVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202790 QORA AEON STOOL MANAGEMENT SYSTEM KNT CM TECHNOLOGIES INC. MG-12015-003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization