BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 23167585 · Received September 29, 2025

    Report

    Report Number
    3010757606-2025-00426
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    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 062918. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE A PATIENT IN THE NETHERLANDS UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY-JEJUNAL (PEG-J) TUBES. ON (B)(6) 2025 IT WAS REPORTED THE PATIENT HAS BEEN IN THE HOSPITAL SINCE LAST TUESDAY DUE TO ABDOMINAL PAIN AND SIGNIFICANT WEIGHT LOSS. PATIENT HAD A GASTROINTESTINAL EXAMINATION AND A CT SCAN ON (B)(6) 2025 WITH UNKNOWN RESULTS. PATIENT'S HUSBAND STATED THE PEG-J WAS REPLACED LAST YEAR AND THAT SOMETHING MUST HAVE GONE WRONG, CAUSING IRRITATION TO THE SMALL INTESTINE. THE PUMP HAS BEEN STOPPED AND THE PEG-J WILL BE REMOVED TOMORROW TO REST THE SMALL INTESTINE. IT IS UNKNOWN HOW LONG IT WILL TAKE BEFORE THE PEG-J IS REPLACED AND THE PUMP IS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943863 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32491240

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H PEG TUBE/ LOT# 32121211