BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 20625365 · Received November 6, 2024

    Report

    Report Number
    3010757606-2024-10178
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 6, 2024
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062912. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO 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) 2021, A PATIENT IN AUSTRALIA UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. IN (B)(6) 2024, THE PATIENT EXPERIENCED STOMA SITE CELLULITIS WHICH WAS TREATED WITH FLUCLOXACILLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416767 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention UNKNOWN INTESTINAL TUBE, UNKNOWN LOT#