BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA

    MDR report key: 21574749 · Received March 11, 2025

    Report

    Report Number
    3013524793-2023-00001
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    November 28, 2023
    Manufacturer
    CM TECHNOLOGIES INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS CLASSIFIED AS A SERIOUS INJURY BASED ON THE AVAILABLE INFORMATION. WITHIN THE COMPLAINT THAT WAS INITIATED FOR THIS EVENT A DETAILED INVESTIGATION OF BATCH RECORDS AND TESTING OF RETENTION 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 VIA POST MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    PATIENT SAFETY ISSUES RELATED TO RECTAL BLEEDING WAS REPORTED. ONE OF THE PATIENTS REQUIRED SURGICAL INTERVENTION AND TWO OTHERS REQUIRED EMBOLECTOMIES TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335587 QORA STOOL MANAGEMENT SYSTEM KNT CM TECHNOLOGIES INC. EFMG-22014-002 142302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization