BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECCA

    MDR report key: 2326078 · Received October 28, 2011

    Report

    Report Number
    3007729452-2011-00002
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    September 12, 2011
    Report Date
    October 31, 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. PRELIMINARY DISCUSSIONS DURING INITIAL INVESTIGATION INCLUDED TREATMENT OPTIONS OF ORAL ANTIBIOTICS AND ANALGESICS, AND RECOMMENDED REPEAT EXAM IN 6-8 WEEKS AS HEALING WOULD BE ANTICIPATED. THIS WOULD BE SIMILAR TO THE PROCESS OF HEALING OF THE ANORECTUM AFTER SIMILAR TYPES OF PROCEDURES. FURTHER INVESTIGATION IS CONTINUING.

    Description of Event or Problem · 1

    PATIENT BEGAN TO COMPLAIN OF ANAL PAIN AND BRIGHT RED BLOOD PER RECTUM TO DOCTOR APPROXIMATELY 5 DAYS AFTER RADIOFREQUENCY TREATMENT OF THE ANAL CANAL (SECCA PROCEDURE). THE PATIENT WAS EXAMINED AND WAS FOUND TO HAVE A THERMAL MUCOSAL INJURY FOR ABOUT 40-50 PERCENT OF THE CIRCUMFERENCE WITH INFECTION AND NECROSIS.

    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