BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 7113520 · Received December 13, 2017

    Report

    Report Number
    3010757606-2017-00587
    Event Type
    Death
    Date Received
    December 13, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062943-001 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 WAS NOT RETURNED, IT WAS DISCARDED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. INTESTINAL OBSTRUCTION IS A KNOWN COMPLICATION OF USE OF DEVICE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2017, PATIENT WENT TO THE EMERGENCY ROOM DUE TO ABDOMINAL PAIN AND WAS DIAGNOSED WITH INTESTINAL OBSTRUCTION. THE PATIENT WAS SCHEDULED FOR SURGERY THE FOLLOWING DAY. ON (B)(6) 2017, THE PATIENT PASSED AWAY. IT IS UNKNOWN WHAT PART OF THE INTESTINE WAS OBSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894507 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R ABBVIE PEG TUBE - LOT NUMBER UNK.