BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 8214580 · Received January 3, 2019

    Report

    Report Number
    3010757606-2019-00005
    Event Type
    Injury
    Date Received
    January 3, 2019
    Report Date
    December 11, 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

    REFERENCE RECORD (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 REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED; 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 NASO JEJUNAL (NJ) TUBE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ACUTE RESPIRATORY FUNCTION DECOMPENSATION AFTER THE NASAL TUBE PLACEMENT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. FURTHER TREATMENT INFORMATION WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7368 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1085275

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O