BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 17341213 · Received July 18, 2023

    Report

    Report Number
    3010757606-2023-00492
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 17, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    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. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION CANNOT BE PERFORMED. STOMA SITE INFECTION 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) 2019, A PATIENT IN GREECE UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2023, THE PATIENT WAS SEEN AT HOME AND HAD A PRODUCTIVE GRANULOMA WITH PUS-LIKE DISCHARGES FROM THE STOMA. THE PATIENT'S PHYSICIAN PRESCRIBED AUGMENTIN 1000 MG (875+125) TWICE A DAY FOR SEVEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840676 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32384356

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention UNKNOWN INTESTINAL TUBE, UNKNOWN LOT#