BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE NJ

    MDR report key: 7852694 · Received September 6, 2018

    Report

    Report Number
    3010757606-2018-00517
    Event Type
    Death
    Date Received
    September 6, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 14, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062903-002 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION, IT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION WAS NOT PERFORMED. IT IS UNABLE TO DETERMINE IF THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, PATIENT IN (B)(6) HAD A NASO JEJUNAL TUBE PLACED. AFTER AN UNSPECIFIED PERIOD OF TIME ON THE SAME DAY, THE PATIENT REGURGITATED THE NASAL TUBE. IT WAS PLANNED TO PLACE A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2018, ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THE PATIENT PASSED AWAY. THOUGH REQUESTED, ADDITIONAL INFORMATION INCLUDING CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693372 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1079743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other