BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 8019723 · Received October 30, 2018

    Report

    Report Number
    3010757606-2018-00641
    Event Type
    Death
    Date Received
    October 30, 2018
    Date of Event
    September 1, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062941-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED WHICH IS THE US LIST NUMBER. THE DEVICE MANUFACTURER AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE DEVICE INVOLVED WAS ABBVIE BRANDED TUBING. ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ASPIRATION PNEUMONIA IS A KNOWN COMPLICATION OF A PEG- 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 REPLACEMENT OF THE PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE. AFTER THE PEJ REPLACEMENT, THE PATIENT DEVELOPED PNEUMONIA AND DIED ON (B)(6) 2018 IN THE CLINIC. IT WAS UNKNOWN IF THIS WAS ASPIRATION PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860597 ABBVIE J TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PEG TUBE, UNKNOWN MANUFACTURER