BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 11700863 · Received April 21, 2021

    Report

    Report Number
    3010757606-2021-00255
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 AN UNKNOWN DATE, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. IN (B)(6) 2021, THE PATIENT EXPERIENCED A LEAKING STOMA SITE AND WAS PRESCRIBED ORAL FLUCLOXACILLIN 1G X 2 FOR 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601822 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ABBVIE J-TUBE, LOT # UNKNOWN