BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA STOOL RECTAL DEVICE MANAGEMENT KIT

    MDR report key: 20558173 · Received October 28, 2024

    Report

    Report Number
    MW5161755
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 21, 2024
    Manufacturer
    CM TECHNOLOGIES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LIKELY LOW RECTAL BLEED POSSIBLY SECONDARY TO TRAUMATIC ULCERATION CAUSED BY RECTAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726004 QORA STOOL RECTAL DEVICE MANAGEMENT KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CM TECHNOLOGIES, INC. MG22014002 132410

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention