BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 15110848 · Received July 27, 2022

    Report

    Report Number
    3010757606-2022-00490
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    September 30, 2020
    Report Date
    July 27, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IT WAS UNKNOWN IF THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED OR WILL BE RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. HOWEVER, IF THE DEVICE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE RETURN SAMPLE INVESTIGATION. A DUODENAL ULCER 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 JAPAN UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE (J-TUBE). ON (B)(6) 2020, THE PATIENT EXPERIENCED AN ULCER IN THE DUODENUM. ON (B)(6) 2020, THE ULCER IN THE DUODENUM RESOLVED. IT WAS UNKNOWN IF THE PATIENT RECEIVED ANY TREATMENT OR MEDICAL INTERVENTIONS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572349 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other PEG TUBE, UNKNOWN MANUFACTURER