BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 24190812 · Received January 27, 2026

    Report

    Report Number
    3010757606-2026-00032
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 27, 2026
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. AN ULCER IS A KNOWN COMPLICATION OF A J-TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A CONTROL ENDOSCOPY ON (B)(6) 2026 DUE TO ABDOMINAL PAIN. UPON OBSERVING AN ULCER IN THE JEJUNUM, THE PEGJ WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253318 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32251523

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention ABBVIE PEG TUBE, LOT # 32431371