BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 18388020 · Received December 22, 2023

    Report

    Report Number
    3010757606-2023-00879
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 1, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). 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. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A BOWEL PERFORATION 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 · 0

    ON AN UNKNOWN DATE A PATIENT IN GERMANY UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE (J-TUBE). IN (B)(6) 2023 THE PATIENT EXPERIENCED INFLAMMATION IN THE ABDOMINAL CAVITY IN WHICH A PHYSICIAN SUSPECTED GALLBLADDER INFLAMMATION. ON (B)(6) 2023 THE PATIENT UNDERWENT AN OPERATION AT A CLINIC IN WHICH GALLBLADDER INFLAMMATION WAS RULED OUT AND A HOLE IN THE DUODENUM WAS DISCOVERED. THE PATIENT WAS TRANSFERRED TO A GERIATRIC MEDICAL CENTER AND IT WAS UNKNOWN IF THE PATIENT RECEIVED ANY SYSTEMIC TREATMENT OR MEDICAL INTERVENTIONS. APPROXIMATELY ON (B)(6) 2023, THE TUBING WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609511 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| O PEG TUBE, UNKNOWN MANUFACTURER