BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 8709453 · Received June 18, 2019

    Report

    Report Number
    3010757606-2019-00410
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: WAS: CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062903. IS: CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062903. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A GI BLEED IS A KNOWN COMPLICATION OF 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) 2017, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2019 IT WAS REPORTED THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR BLACK VOMITING. AN ENDOSCOPY WAS PERFORMED AND A HEMORRHAGE IN THE DUODENUM WAS DETECTED. INTRAVENOUS SEROTHERAPY WAS ADMINISTERED IN ORDER TO STOP THE BLEEDING. LAB TESTS WERE PERFORMED AND THE PLAN WAS TO TRANSFUSE BLOOD TO THE PATIENT. THE PERCUTANEOUS INTESTINAL TUBE WAS REMOVED, AND PATIENT CONTINUES TO RECEIVE DUODOPA CONNECTED VIA THE PUMP TO THE GASTRIC PORT. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500172 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32045196

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R ABBVIE PEG TUBE, LOT # 32294374