BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 19497739 · Received June 10, 2024

    Report

    Report Number
    3010757606-2024-000034
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IN D4 IS THE SIMILAR US LIST NUMBER, THE INTERNATIONAL LIST NUMBER IS UNKNOWN. THE DEVICE MANUFACTURER AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE DEVICE INVOLVED WAS ABBVIE BRANDED TUBING. ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. THE DISPOSITION OF THE DEVICE INVOLVED IS UNKNOWN; THEREFORE, IT IS UNKNOWN IF A RETURN SAMPLE EVALUATION IS ABLE TO BE PERFORMED. H6 CODE OF 4581 WAS CHOSEN TO CAPTURE THE EVENT OF POST PROCEDURAL COMPLICATION AT THE SITE OF A DIRECT JEJUNOSTOMY. POST PROCEDURAL COMPLICATIONS ARE KNOWN COMPLICATIONS OF A PEG TUBE/ 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) 2024, A PATIENT IN THE NETHERLANDS UNDERWENT A PROCEDURE FOR THE PLACEMENT OF A PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT WAS ADMITTED URGENTLY DUE TO SEVERE INFLAMMATION IN HIS PEJ. ON (B)(6) 2024 THE TUBING WAS URGENTLY REMOVED. ON (B)(6) 2024, AN NS-J TUBE WAS REINSTALLED. IT WAS NOT EXPECTED THAT A NEW PEJ WOULD BE INSTALLED. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE EVENTS REPORTED WITHOUT SUCCESS. BASED ON THE INFORMATION PROVIDED THIS COMPLAINT HAS BEEN ASSESSED AS A POST PROCEDURAL COMPLICATION AT THE SITE OF A DIRECT JEJUNOSTOMY SITE WITH AN UNKNOWN INTESTINAL TUBE, CONSERVATIVELY CONSIDERED TO BE ABBVIE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205296 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R