BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 16397311 · Received February 17, 2023

    Report

    Report Number
    3010757606-2023-00126
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). CATALOG NUMBER 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 CANNOT BE PERFORMED. CODE OF 4581 WAS CHOSEN TO CAPTURE THE EVENT OF BEZOAR. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT IN ITALY UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2022, THE DEVICE WAS REPLACED DUE TO A BEZOAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173909 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention UNKNOWN PEG, UNKNOWN LOT#.