BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 15846025 · Received November 22, 2022

    Report

    Report Number
    3010757606-2022-00755
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 3, 2023
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). THE DEVICE INVOLVED IN THE EVENT REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. (B)(4). BURIED BUMPER SYNDROME IS A KNOWN COMPLICATION OF A PEG TUBE/ 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 AUSTRALIA UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INABILITY TO MOVE PEG TUBE BI DIRECTIONALLY. ON (B)(6) 2022, THE PATIENT UNDERWENT A CT SCAN WHICH CONFIRMED BURIED BUMPER SYNDROME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT UNDERWENT BURIED BUMPER REMOVAL WHICH WAS UNSUCCESSFUL AS "THE BUMPER WAS TOO BURIED IN TO THE ABDOMINAL WALL. ON (B)(6) 2022, THE PATIENT UNDERWENT SUCCESSFUL BURIED BUMPER REPAIR BY THE SURGEON. IT WAS REPORTED THAT THE PATIENT RECEIVED NEW 15FR PEG AND 9 FR J TUBE IN A NEW STOMA SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725754 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Prefer Not To Disclose Required Intervention UNKNOWN J-TUBE, LOT # UNKNOWN