BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6888953 · Received September 22, 2017

    Report

    Report Number
    3010757606-2017-00437
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 5, 2017
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER (B)(4) 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 OR WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR IS A KNOWN COMPLICATION OF A PEJ 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, A PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY/JEJUNAL (PEG-J) TUBE. ON (B)(6) 2017, THE PATIENT HAD A REPLACEMENT OF HIS PEJ TUBE DUE TO AN OBSTRUCTION. AT THAT TIME, THE DOCTOR OBSERVED THE PRESENCE OF BEZOAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665732 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention