BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

    MDR report key: 21273273 · Received January 30, 2025

    Report

    Report Number
    21273273
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 10, 2025
    Manufacturer
    C. R. BARD, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT WITH FCD (FUNCTIONAL COGNITIVE DISORDER/FOCAL CORTICAL DYSPLASIA- A SORT OF MEMORY LOSS) HAD LEAKAGE AROUND DEVICE. PATIENT TURNED ON SIDE TO CLEAN UP. IRRIGATION PORT OF FCD FOUND DISCONNECTED LYING NEXT TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681952 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT C. R. BARD, INC. SMS002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male