BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 10462809 · Received August 27, 2020

    Report

    Report Number
    3010757606-2020-00553
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). THE Y-CONNECTOR, CLICK ADAPTOR, PEG-TUBE, AND J-TUBE WERE RETURNED. THE PEG AND J TUBES WERE RECEIVED CUT INTO TWO PIECES. THIS DAMAGE LIKELY OCCURRED WHEN THE TUBING WAS REMOVED FROM THE PATIENT AND WOULD NOT CONTRIBUTE TO THE REPORTED EVENT. A VISUAL INSPECTION WAS PERFORMED. NO ADDITIONAL DAMAGE WAS OBSERVED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON 04 JAN 2021 IT WAS REPORTED THAT DUE TO THE GRANULOMA WORSENING THE PEG-J WAS REMOVED. THE PATIENT WILL REMAIN WITHOUT THE PEG-J UNTIL THE STOMA HEALS. AN NJ WAS PLACED AND THE PATIENT WILL RECEIVE DUODOPA FROM THE NJ UNTIL THE DATE OF PEG-J RE-PLACEMENT. IT WAS REPORTED THAT THE STOMA AT THIS STAGE SHOWS NO INFECTION, ONLY THE GRANULOMA REMAINS. ON (B)(6) 2021 THE PATIENT HAD THE PEG-J REPLACED.

    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; 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) 2018 A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. IT WAS REPORTED 10 AUGUST 2020 THAT THE OSTOMY WAS EVALUATED BY A GASTROENTEROLOGIST IN JUNE AND A NEW GRANULOMA WAS FOUND WITH FLUID DISCHARGE. A FLUID SAMPLE FROM THE STOMA SITE WAS SENT FOR CULTURE AND STAPHYLOCOCCUS AND FUNGI WERE FOUND. THE PATIENT RECEIVED UNKNOWN ANTIBIOTIC TREATMENT. THE GRANULOMA NOW SHOWS IMPROVEMENT. INSTRUCTIONS FOR CARE OF THE STOMA SITE WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925880 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention UNKNOWN J-TUBE, MANUFACTURER UNKNOWN