BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QORA FLEXISEAL STOOL MANAGEMENT KIT

    MDR report key: 19499778 · Received June 7, 2024

    Report

    Report Number
    MW5156000
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 5, 2024
    Report Date
    June 5, 2024
    Manufacturer
    CM TECHNOLOGIES, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRITICALLY ILL PATIENT HAD A FLEXISEAL RECTAL TUBE PLACED FOR STOOL MANAGEMENT. TUBE REMOVED ON (B)(6) AND SUBSEQUENTLY PT HAD SEVERAL EPISODES OF BRBPR AND COFFEE GROUND-APPEARING RECTAL EFFLUENT SINCE. HEPARIN GTT STOPPED, HBG 7.5 PATIENT RECEIVED 2 UNITS OF PRBC, HGBS WERE THEN IN 9 - 8.5 - 9 RANGE. NO FURTHER BLOOD TRANSFUSIONS WERE REQUIRED AFTER (B)(6) 2024. SURGEON NOTED THAT RECTAL BLEEDING MOST LIKELY DUE TO ULCERATION FROM RECTAL MUCOSAL TRAUMA FROM RECTAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184248 QORA FLEXISEAL STOOL MANAGEMENT KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CM TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention