BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYGH-TEC

    MDR report key: 23390346 · Received October 27, 2025

    Report

    Report Number
    23390346
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ADVANCED MEDICAL BALLOONS GMBH
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A FECAL MANAGEMENT SYSTEM (FMS) IN, INITIAL ONE WAS PLACED [REDACTED] REMOVED [REDACTED]- 4 DAYS LATER. A NEW ONE PLACED ON THE SAME DAY AND REMOVED ON [REDACTED] - 2 DAYS LATER - DUE TO BALLON LEAKING AIR AND SYSTEM LEAKING. WHEN FMS REMOVED PATIENT ALSO NOTED TO HAVE A PRESSURE INJURY ON RECTUM BELIEVED TO BE FROM HARD PLASTIC ON FMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308291 HYGH-TEC TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ADVANCED MEDICAL BALLOONS GMBH V01-10024 2414001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female