BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 801249 · Received December 30, 2006

    Report

    Report Number
    1226693-2006-00002
    Event Type
    Injury
    Date Received
    December 30, 2006
    Date of Event
    November 22, 2005
    Report Date
    December 29, 2006
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    k032820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THERE IS NO APPARENT MALFUNCTION IN THIS INSTANCE. THERE HAVE BEEN FREQUENT PREVIOUS REPORTS OF SUSTAINED, SIGNIFICANT, POST PROCEDURE DISCOMFORT IN PATIENTS WHO HAVE RECEIVED PLICATOR GERD THERAPY. IN ALL CASES, SYMPTOMS RESOLVED UPON REVERSAL OF THE PLICATOR PROCEDURE. WE WILL CONTINUE TO MONITOR THE FREQUENCY OF SUCH REPORTS GOING FORWARD.

    Description of Event or Problem · 1

    A FEMALE COMPLAINED OF PERSISTENT POST-TREATMENT NAUSEA, VOMITING, AND SLIGHT DYSPHASIA. SHE REQUESTED REVERSAL OF HER PLICATOR TREATMENT. THE PLICATOR TREATMENT WAS SUCCESSFULLY REVERSED VIA ENDOSCOPIC INTERVENTION 4 MONTHS SUBSEQUENT TO THE INITIAL TREATMENT. THE PT REPORTED "100% RECOVERY (NO EMESIS OR PAIN)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPE/ACCESSORY KOG NDO SURGICAL, INC. 160-1130 05-0215

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention