BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPS/PLICATOR

    MDR report key: 867221 · Received June 14, 2007

    Report

    Report Number
    1226693-2007-00004
    Event Type
    Injury
    Date Received
    June 14, 2007
    Date of Event
    May 31, 2006
    Report Date
    June 14, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    K032280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY PARTICIPANT EXPERIENCED PNEUMOPERITONEUM AND ASSOCIATED ABDOMINAL AND CHEST PAIN SUBSEQUENT TO BEING TREATED WITH THE PLICATOR. THE PT ALSO EXPERIENCED ELEVATED C-REACTIVE PROTEIN LEVELS (25.9 MG/DL) AND AS A RESULT WAS HOSPITALIZED FOR 5 DAYS OF IV ANTIBIOTIC THERAPY (MEZLOCILLIN 6G/ DAY AND METRONIDAZOL 1.5G/ DAY). THERE WAS NO EVIDENCE OF LEUCOCYTOSIS OR FEVER. THERE WAS NO DEVICE MALFUNCTION. THE PATIENT WAS RELEASED FROM THE HOSP WITH ALL ISSUES RESOLVED AND NO FURTHER COMPLAINTS. THE PT'S GERD SYMPTOMS WERE WELL CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPS/PLICATOR ENDOSCOPE/ACCESSORY KOG NDO SURGICAL, INC. 160-01130 060003

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R