BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 8254683 · Received January 16, 2019

    Report

    Report Number
    3010757606-2019-00034
    Event Type
    Death
    Date Received
    January 16, 2019
    Date of Event
    December 30, 2018
    Report Date
    December 30, 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

    REFERENCE RECORD (B)(4). 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. CONSERVATIVELY, 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 NOT RETURNED AND WAS DISCARDED; 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) 2016, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2018, THE PATIENT HAD A J-TUBE REPLACEMENT DUE TO A J-TUBE DISLOCATION AND WAS DISCHARGED THE SAME DAY. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA. ON (B)(6) 2018, THE PATIENT DIED DUE TO PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46768 ABBVIE J TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H FREKA PEG TUBE, LOT # 32191186