BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 11156345 · Received January 12, 2021

    Report

    Report Number
    3010757606-2021-00026
    Event Type
    Injury
    Date Received
    January 12, 2021
    Report Date
    January 12, 2021
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    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. A BEZOAR WAS PRESENT ON THE PIGTAIL OF THE J-TUBE SURROUNDING A KNOT IN THE J-TUBE. THE PROBABLE CAUSE FOR THE KNOT IN THE J-TUBE COULD BE DUE TO NATURAL MOVEMENT IN THE BODY. KNOTTING AND BEZOARS ARE KNOWN COMPLICATIONS OF USE OF THE DEVICE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. (B)(4). A BEZOAR IS A KNOWN COMPLICATION OF A J 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) 2020 A PATIENT IN GREECE UNDERWENT A PROCEDURE FOR THE RE-PLACEMENT OF A JEJUNAL (PEG-J) TUBE. ON (B)(6) 2020 IT WAS REPORTED THAT DUE TO WORSENING GRANULOMA IN THE STOMA AREA, THE PEG-J WAS REMOVED BY THE GASTROENTEROLOGIST. DURING REMOVAL OF THE INTESTINAL TUBE, A BEZOAR AND MULTIPLE KNOTS WERE OBSERVED. THE PATIENT WILL REMAIN WITHOUT THE PEG-J UNTIL THE STOMA SITE HEALS AND WILL THEN BE RE-PLACED. AN NJ WAS PLACED AND THE PATIENT WILL RECEIVE DUODOPA FROM THE NJ UNTIL THE PEG-J RE-PLACEMENT. THE STOMA SITE SHOWS NO INFECTION; ONLY THE GRANULOMA IS PRESENT. THE PATIENT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50649 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32041278

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ABBVIE PEG TUBE, LOT # 32064207.| ABBVIE PEG TUBE, LOT # 32064207