BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 6351488 · Received February 22, 2017

    Report

    Report Number
    3010757606-2017-00089
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 6, 2017
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD: (B)(4). AFTER THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, IT WAS NOTED THAT THE MANUFACTURER OF THE DEVICE IS NOT ABBVIE INC; THEREFORE ABBVIE HAS NO REPORTING RESPONSIBILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BURIED BUMPER SYNDROME IS A KNOWN COMPLICATION OF A PEG TUBE PLACEMENT. 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, PATIENT IN FINLAND UNDERWENT PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. THE TUBES WERE NOT MOVING AT STOMA SITE AND THE STOMA SITE WAS PAINFUL. REPORT INDICATED THE PATIENT EXPERIENCED BURIED BUMPER SYNDROME. THE PEG WILL BE REMOVED AND PLACED AT A NEW SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133635 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention J TUBE- MANUFACTURER UNK