BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 16152732 · Received January 12, 2023

    Report

    Report Number
    3010757606-2023-00031
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 1, 2022
    Report Date
    January 12, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER 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) 2022, A PATIENT IN TURKEY UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2022, THE PATIENT BEGAN AUGMENTIN TREATMENT FOR REDNESS AT THE PEG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464592 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32141140

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention ABBVIE J TUBE, LOT # 32391321.