BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    MDR report key: 22105514 · Received May 29, 2025

    Report

    Report Number
    MW5170864
    Event Type
    Death
    Date Received
    May 29, 2025
    Date of Event
    June 18, 2022
    Report Date
    May 28, 2025
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE REPORTER RESPONDED TO CALL TO MAKE COMPLAIN REGARDING DEVICE FLEXI-SEAL FECAL MANAGEMENT SYSTEM. THE REPORTER SAID HER HUSBAND WAS IN INTENSIVE CARE UNIT FOR TREATMENT OF HEART ATTACK. SHE ALSO MENTIONED HE WAS ON BLOOD THINNER AND ANTIBIOTICS WHICH WAS INFORMED TO THE HEALTH CARE SERVICE PROVIDERS IN THE INTENSIVE CARE UNIT. DURING THE TIME IN ICU, HE HAD DIARRHEA AND FLEXI-SEAL FECAL MANAGEMENT SYSTEM WAS INSERTED ON (B)(6) 2025. THE CALLER STATED, "THE DEVICE WAS USED ON MY HUSBAND WITHOUT CONSENT AND WITHOUT RECORDS OR DOCUMENTATIONS." HE EXPERIENCED VOMITING, ABDOMINAL DISTENTION AND RECTAL BLEEDING. THE TUBE WAS REMOVED ON (B)(6) 2025. HE PASSED AWAY ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746325 FLEXI-SEAL FECAL MANAGEMENT SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC, INC. 0272

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Death TAB WARFARIN