BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 20989026 · Received December 20, 2024

    Report

    Report Number
    3010757606-2024-10255
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BURIED BUMPER SYNDROME IS A KNOWN COMPLICATION OF A PEG- J 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 THE UNITED KINGDOM UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY-JEJUNAL (PEG-J) TUBES. ON (B)(6) 2024 IT WAS REPORTED THE PATIENT WAS UNABLE TO ADVANCE THE TUBE. POSSIBLE BURIED BUMPER SYNDROME. A PEG-J RE-PLACEMENT IS PLANNED FOR (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164784 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention UNKNOWN INTESTINAL TUBE/ LOT#