BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 15059067 · Received July 19, 2022

    Report

    Report Number
    3010757606-2022-00479
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    July 2, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BURIED BUMPER 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 (B)(6) 2021, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2022, DURING THE GASTROSCOPIC VISIT FOR THE PEG/PEJ CHANGE, THE BURIED BUMPER SYNDROME WAS DETECTED. THEREFORE, THE PEG WAS REMOVED AND A GASTROSCOPIC SESSION HAS BEEN RESCHEDULED. ON (B)(6) 2022, THE MD REPORTED THAT, FOLLOWING THE PRESENCE OF AN ABDOMINAL INFLAMMATORY SITUATION, IT WAS DECIDED TO RESCHEDULE THE REPOSITIONING OF THE PEG/PEJ TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312739 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention J TUBE, UNKNOWN MANUFACTURER