BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6725531 · Received July 19, 2017

    Report

    Report Number
    3010757606-2017-00322
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 29, 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 MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, IT WAS THROWN AWAY; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A KNOTTED TUBE IS A KNOWN COMPLICATION OF AN INTESTINAL TUBE USAGE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT IN (B)(6) HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J) TUBE PLACEMENT. ON (B)(6) 2017 THE PEG/PEJ SYSTEM HAD BEEN REPLACED DUE TO PEJ KNOT ON ITSELF AT THE DISTAL EXTREMITY THE TUBE WAS DISCARDED. THE NEW SYSTEM WORKED WITHOUT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506027 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention