BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 8464400 · Received March 29, 2019

    Report

    Report Number
    3010757606-2019-00205
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 14, 2019
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 · 1

    ON (B)(6) 2017, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE REPLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2019, IT WAS REPORTED THAT THE PEG AND THE PEJ WILL BE REPLACED DUE TO A BURIED BUMPER. THE PEG/PEJ ARE REPLACED ON AN OUTPATIENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257023 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32384356

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ABBVIE J TUBE, LOT # 32344336