BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 24323488 · Received February 12, 2026

    Report

    Report Number
    3010757606-2026-00051
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062912. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062912. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. 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 (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2026, THE PATIENT WAS PRESCRIBED TOPICAL FUCIDIN AND ORAL AUGMENTIN FOR 10 DAYS FOR A STOMA INFECTION. ON (B)(6) 2026, IT WAS REPORTED THAT THE STOMA AND GRANULOMA WERE IMPROVING AND THE PATIENT HAD A TUBING REPLACEMENT SCHEDULED. ON (B)(6) 2026, IT WAS REPORTED THAT DURING THE SCHEDULED REPLACEMENT, THE GASTROENTEROLOGIST ASSESSED THE STOMA/GRANULOMA AND ADMINISTERED INTRAVENOUS ANTIBIOTIC DURING THE PROCEDURE AND PRESCRIBED A COURSE OF UNKNOWN ORAL ANTIBIOTICS. ON (B)(6) 2026, THE PATIENT WAS PRESCRIBED AN ANTIFUNGAL OINTMENT (MICONAZOLE) FOR 10 DAYS BECAUSE THE STOMA CULTURE SHOWED FUNGUS. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT IN SPAIN UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2026, THE PATIENT WAS PRESCRIBED TOPICAL FUCIDIN AND ORAL AUGMENTIN FOR 10 DAYS FOR A STOMA INFECTION. ON (B)(6) 2026, IT WAS REPORTED THAT THE STOMA AND GRANULOMA WERE IMPROVING AND THE PATIENT HAS A TUBING REPLACEMENT SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385320 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32041372

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention ABBVIE INTESTINAL TUBE, LOT#32351381| ABBVIE INTESTINAL TUBE, LOT#32351381