BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13621770 · Received February 28, 2022

    Report

    Report Number
    3010757606-2022-00122
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 28, 2022
    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 RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DISPOSITION OF THE DEVICE INVOLVED IN THE EVENT WAS UNKNOWN; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. INTESTINAL 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.

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DISPOSITION OF THE DEVICE INVOLVED IN THE EVENT WAS UNKNOWN; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. INTESTINAL 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 NETHERLANDS UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED DUE TO A SMALL INTESTINAL PERFORATION CAUSED BY THE INTESTINAL TUBE. IT WAS UNKNOWN IF THE J-TUBE WAS REMOVED OR WHAT INTERVENTIONS THE PATIENT RECEIVED FOR THE PERFORATION.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, A PATIENT IN NETHERLANDS UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED DUE TO A SMALL INTESTINAL PERFORATION CAUSED BY THE INTESTINAL TUBE. IT WAS UNKNOWN IF THE J-TUBE WAS REMOVED OR WHAT INTERVENTIONS THE PATIENT RECEIVED FOR THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800410 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32183216

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R PEG TUBE - UNKNOWN MANUFACTURER AND LOT #