BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 24190758 · Received January 27, 2026

    Report

    Report Number
    3010757606-2026-00031
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 27, 2026
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODE OF E2402 WAS CHOSEN TO CAPTURE THE EVENT OF A POST PROCEDURAL COMPLICATION. CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS THE SAME US LIST NUMBER OF 062903. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. AN UNKNOWN POST PROCEDURAL COMPLICATION IS A KNOWN COMPLICATION OF A NJ 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) 2026, A PATIENT IN AUSTRALIA UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE (J-TUBE). IT WAS REPORTED THAT THE PATIENT'S NJ TUBE WAS "IN SITU" AND WAS ADMITTED TO THE ICU. THE PATIENT EXPERIENCED AN UNKNOWN POST PROCEDURAL COMPLICATION. THE STATUS OF THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249146 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R