BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 23325877 · Received October 17, 2025

    Report

    Report Number
    3010757606-2025-00450
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 17, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 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 UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. ON (B)(6) 2025 THE PATIENT EXPERIENCED A STOMA SITE INFECTION AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON (B)(6) 2025 THE PATIENT EXPERIENCED A BAD SMELL FROM THE STOMA SITE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 IN WHICH THE PATIENT HAD EXUDATE WITH GASTRIC CONTENTS THAT LOOKED PURULENT AND A SWOLLEN ABDOMEN. THE PATIENT WAS SEEN WITH AN NRL AND WAS PRESCRIBED ORAL AMOXY-CLAV (ATP) AND AN ABDOMINAL PLATE TO RULE OUT INTESTINAL SUB OCCLUSION WITH A TUBING REPLACEMENT IN (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2860855 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention ABBVIE J-TUBE, LOT # UNKNOWN.