BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 12359985 · Received August 24, 2021

    Report

    Report Number
    3010757606-2021-00586
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 24, 2021
    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 · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. 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. STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG 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) 2021, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED STOMA SITE INFLAMMATION, WHICH WAS TREATED WITH AUGMENTIN (875 + 125) MG. ORAL ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257622 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32071110

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ABBVIE J-TUBE - LOT # 32071120