BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 6688899 · Received July 6, 2017

    Report

    Report Number
    3010757606-2017-00304
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    April 1, 2017
    Report Date
    April 20, 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

    REFERENCE RECORD: (B)(4). CATALOG NUMBER 062943-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT WHICH IS THE US LIST NUMBER. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION THE COMPLAINT CONDITION OF INTESTINAL TUBE - KNOTTED WAS VERIFIED. THE CAUSE OF THE KNOT IS UNABLE TO BE DETERMINED. 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 A PATIENT FROM (B)(6) HAD A PERCUTANEOUS ENDOSCOPIC JEJUNAL (PEJ) TUBE REPLACEMENT FOR AN UNKNOWN INDICATION. IN (B)(6) 2017 THE PEJ DISLOCATED AND WAS REPLACED. UPON EVALUATION OF THE RETURNED TUBING A KNOT IS VISIBLE NEAR THE BOLUS NO OTHER DAMAGE COULD BE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470984 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32041136

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PEG TUBE MANUFACTURER UNK