BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6276361 · Received January 25, 2017

    Report

    Report Number
    3010757606-2017-00033
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    January 1, 2017
    Report Date
    January 5, 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 062943-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN SECTION WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS THROWN AWAY AND NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN (B)(6), PATIENT UNDERWENT PROCEDURE FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG)TUBE PLACEMENT. THE PATIENT BEGAN DUODOPA (B)(6) 2011. THE CURRENT TUBE WAS IN USE SINCE (B)(6) 2016. ON AN UNKNOWN DATE THE PATIENT DEVELOPED A DUODENAL ULCER CAUSED BY THE PEJ. THE PEG-PEJ SYSTEM WAS REMOVED TO ENSURE THE HEALING OF THE DUODENAL LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59926 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PEG TUBE MANUFACTURER UNKNOWN