BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECCA

    MDR report key: 2308248 · Received October 20, 2011

    Report

    Report Number
    3007729452-2011-00001
    Event Type
    Injury
    Date Received
    October 20, 2011
    Date of Event
    September 9, 2011
    Report Date
    October 20, 2011
    Manufacturer
    MEDERI THERAPEUTICS INC.
    Product Code
    GEI
    PMA / PMN Number
    K014216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECCA DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE, AND WAS NOT AVAILABLE FOR INSPECTION. HOWEVER DEVICES FROM THE SAME LOT WERE INSPECTED, TESTED AND PERFORMED AS EXPECTED. PT HAD PREVIOUS FISTULA IN THE SAME AREA AS THIS EVENT.

    Description of Event or Problem · 1

    PT COMPLAINED OF PAIN TO DOCTOR 10 DAYS AFTER RADIOFREQUENCY TREATMENT OF THE ANAL CANAL (SECCA PROCEDURE). EXAM FOUND FISTULA IN SAME AREA AS PREVIOUS FISTULA. FISTULA WAS REPAIRED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECCA ELECTROSURGICAL DEVICE GEI MEDERI THERAPEUTICS INC. 8000 180-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention