BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 8102745 · Received November 26, 2018

    Report

    Report Number
    3010757606-2018-00701
    Event Type
    Injury
    Date Received
    November 26, 2018
    Report Date
    October 31, 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 WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT AVAILABLE OR DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A BEZOAR 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 · 1

    ON (B)(6) 2018, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF NASO JEJUNAL (NJ) TUBE. ON (B)(6) 2018 A BEZOAR WAS NOTED WHILE REMOVING THE NASAL JEJUNAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943136 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1086244

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other