BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 25201712 · Received May 18, 2026

    Report

    Report Number
    3010757606-2026-00151
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 062910. 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 AN UNKNOWN DATE A PATIENT IN AUSTRALIA UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY-JEJUNAL (PEG-J) TUBES. ON (B)(6) 2026 IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A PAINFUL STOMA AND DISCHARGE FROM THE STOMA. PATIENT HAD AN ULTRASOUND AND AN XRAY WITH UNKNOWN RESULTS. PEG-J IS VERY OLD AND THE HOSPITAL IS ARRANGING FOR A PEG-J REPLACEMENT. PATIENT IS BEING TREATED FOR THE INFECTED STOMA WITH UNKNOWN ORAL ANTIBIOTICS. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535695 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H UNKNOWN INTESTINAL TUBE/ LOT#.