BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE J

    MDR report key: 8126509 · Received December 3, 2018

    Report

    Report Number
    3010757606-2018-00728
    Event Type
    Death
    Date Received
    December 3, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 4, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4).

    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 IMPLANTED IN THE PATIENT; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR AND INTESTINAL ULCERS ARE KNOWN COMPLICATIONS OF A 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, THE PATIENT DIED FOLLOWING COMPLICATIONS AFTER THE DUODENAL RESECTION. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, 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 FELT SICK AND WENT TO THE HOSPITAL BECAUSE OF PEG-J TUBE INWARD TRACTION. AFTER CLINICAL EXAMS, DUODENAL ULCERS WERE FOUND, AND AN EMERGENCY DUODENAL RESECTION WAS PERFORMED. THE PEG-J WAS LEFT IN PLACE DURING THE SURGERY. AFTER SURGERY, THE PATIENT WAS IN INTENSIVE CARE IN A MEDICALLY INDUCED COMA. THE PATIENT AWOKE FROM THE COMA ON AN UNKNOWN DATE. ON A SUBSEQUENT UNKNOWN DATE, IT WAS DETERMINED THAT THE INTESTINAL ULCERS WERE CAUSED BY A PHYTOBEZOAR AT THE END OF THE J-TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965228 ABBVIE J TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R