BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 7465867 · Received April 26, 2018

    Report

    Report Number
    3010757606-2018-00249
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 1, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062903-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, IT HAS BEEN REMOVED AND DISCARDED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. 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, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF NASAL JEJUNAL TUBE (NJ). THE PLACEMENT WAS DIFFICULT DUE TO A PREVIOUS SLEEVE SURGERY ( TO MAKE THE STOMACH SMALLER). ON (B)(6) 2018 IT WAS REPORTED THAT AN X-RAY OF THE THORAX SHOWED THE PATIENT HAS PNEUMONIA. AUGMENTIN TREATMENT WAS STARTED. IT IS PRESUMED TO BE ASPIRATION PNEUMONIA BUT THERE IS NO 100% CERTAINTY. THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307899 ABBVIE NJ KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 1079743

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention