BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 7115349 · Received December 13, 2017

    Report

    Report Number
    3010757606-2017-00591
    Event Type
    Death
    Date Received
    December 13, 2017
    Date of Event
    November 20, 2017
    Report Date
    November 21, 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 (B)(4) IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED AND NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. DUODENAL ULCER 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2017 DURING A PEG/PEG-J SYSTEM REPLACEMENT IN THE HOSPITAL, A DUODENAL ULCER WAS DETECTED WHICH REQUIRED IMMEDIATE SURGERY TO REMOVE PART OF THE INTESTINE. IT WAS REPORTED THAT ON THE SAME DAY, THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS PUT IN A PHARMACOLOGICAL COMA IN THE INTENSIVE CARE UNIT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD ADDITIONALLY EXPERIENCED AN INTESTINAL PERFORATION. ON (B)(6) 2017, THE PATIENT DIED DUE TO COMPLICATIONS RELATED TO THE GASTRO INTESTINAL SURGERY. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE PHYSICIAN STATED THAT THE DUODENAL ULCERATION WAS DUE TO THE PEG TUBE. LOT NUMBER WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891441 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention