BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 23094280 · Received September 19, 2025

    Report

    Report Number
    3010757606-2025-00407
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    April 1, 2024
    Report Date
    September 19, 2025
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). THIS IS A FOLLOW UP REPORT OF PREVIOUSLY SUBMITTED REPORT OF MFR # 3010757606-2024-0000303. ADDITIONAL INFORMATION: A2, A3A, A4 AND D10. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT IN GREECE UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. IN APR 2024, THE PATIENT¿S STOMA SITE WAS IRRITATED, GETTING RED AROUND THE PERIMETER AFTER EATING AND HAD A GRANULOMA WHICH WAS SHRINKING CONSIDERABLY. THERE WAS ALSO SMELLY FLUID DISCHARGES. THE PATIENT¿S GASTROENTEROLOGIST WAS INFORMED. THE PATIENT WAS PRESCRIBED AUGMENTIN 1000MG MORNING AND EVENING, PARIET (1X1) AND A PROBIOTIC FOR 8-10 DAYS. THE PATIENT WAS INSTRUCTED TO STOP THE APPLICATION OF SILVER NITRATE AND DO MORE INTENSIVE CLEANING OF THE STOMA SITE WITH SALINE AND HYDROGEN PEROXIDE SO THAT IT WOULD REMAIN DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760689 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32441130

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention INTESTINAL TUBE/ LOT# 32481341