BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6323608 · Received February 10, 2017

    Report

    Report Number
    3010757606-2017-00070
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 1, 2017
    Report Date
    January 15, 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 WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, TUBE DISPOSED AFTER REPLACEMENT; 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 (B)(6) 2016, PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG)TUBE PLACEMENT. ON AN UNKNOWN DATE THE PATIENT REPORTED THAT THE PEJ WAS VERY HARD TO FLUSH. ON (B)(6) 2017 AN X-RAY REVEALED THAT THE PEJ LAY TO DEEP AND WAS KNOTTED. THE TUBE WAS REPLACED ON (B)(6) 2017. THE TUBE WAS DISCARDED IN ENDOSCOPY AFTER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105771 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32325195

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PEG TUBE MANUFACTURER UNKNOWN