BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 599659 · Received April 29, 2005

    Report

    Report Number
    1226693-2005-00002
    Event Type
    Injury
    Date Received
    April 29, 2005
    Date of Event
    February 18, 2005
    Report Date
    April 29, 2005
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS UNCOMPLICATED AND THE DEVICE AND IMPLANT CARTRIDGE PERFORMED AS INTENDED. THERE WERE NO PROCEDURAL ABNORMALITIES, NOR PRODUCT MALFUNCTIONS. AFTER THE PATIENT WAS DISCHARGED, THEY SUBSEQUENTLY COMPLAINED OF ABDOMINAL PAIN RADIATING TO THEIR RIGHT SHOULDER. THEY WERE EVALUATED AT HOSPITAL EMERGENCY ROOM AND RELEASED. THEY RETURNED WITH PERSISTENT ABDOMINAL PAIN RADIATING TO THEIR UPPER CHEST AND LEUKOCYTOSIS. THEY WAS ADMITTED FOR TREATMENT. INITIAL TREATMENT CONSISTED OF INTRAVENOUS FLUIDS AND ANTIBIOTICS. IN 2005 THEY WERE SYMPTOM FREE, THE LEUKOCYTOSIS HAD NORMALIZED BUT THEY CONTINUED TO HAVE MILD TEMPERATURE ELEVATION. INITIAL CT FOLLOWED BY GASTROGRAFFIN FAILED TO SHOW SIGNIFICANT LEAKAGE OF CONTRAST MATERIAL. THEY WERE DISCHARGED ON P.O. ANTIBIOTICS. THE EVENT WAS CONSIDERED COMPLETELY RESOLVED 3 DAYS LATER, PER THE PHYSICIAN. NDO SURGICAL RECEIVED THE ATTACHED REPORT FORMS VIA FAX 2 MONTHS LATER. AS THERE WAS NO PRODUCT MALFUNCTION, THE PRODUCT WAS NOT RETURNED TO NDO SURGICAL. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME AS TO THE CAUSE OF THIS EVENT. AS THIS IS THE FIRST COMPLAINT OF THIS NATURE, CO WILL CONTINUE TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPIC SURGICAL DEVICE KOG NDO SURGICAL, INC. * 04-0920

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R