BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 7686334 · Received July 13, 2018

    Report

    Report Number
    3010757606-2018-00418
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    July 1, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 IN MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, IT REMAINS IMPLANTED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. AN ULCER IS A KNOWN COMPLICATION OF A NJ 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) 2018, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF A NASAL JEJUNAL TUBE (NJ). ON AN UNKNOWN DATE THE PATIENT WAS DIAGNOSED WITH GASTRIC ULCERS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529885 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1065813

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention