BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 23477875 · Received November 5, 2025

    Report

    Report Number
    3010757606-2025-00479
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. THE DEVICE INVOLVED IN THE EVENT REMAINED IMPLANTED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A PATIENT IN SPAIN UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY-JEJUNAL (PEG-J) TUBES. ON (B)(6) 2025 IT WAS REPORTED THAT PATIENT WAS BEING TREATED FOR A STOMA INFECTION WITH ORAL ANTIBIOTIC AUGMENTIN 875/125, EVERY 8 HOURS FOR 10 DAYS (BEGINNING (B)(6) 2025) AND TOPICAL SILVER DRESSING EVERY 24 TO 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677909 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention UNKNOWN INTESTINAL TUBE/ LOT#.