BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 6913485 · Received October 4, 2017

    Report

    Report Number
    3010757606-2017-00452
    Event Type
    Death
    Date Received
    October 4, 2017
    Date of Event
    August 26, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. 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; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ILEUS IS A KNOWN COMPLICATION OF A J-TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4).

    Description of Event or Problem · 1

    IN(B)(6) 2017, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED DUE TO VOMITING. ON (B)(6) 2017, HE DIED DUE TO SMALL BOWEL ILEUS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN, THE PATIENT DIED ON (B)(6) 2017 FROM SEPSIS IN CONSEQUENCE OF A BOTH-SIDED PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693021 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention FK PEG TUBE, UNKNOWN LOT NUMBER