BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2253974 · Received September 14, 2011

    Report

    Report Number
    1222780-2011-00169
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW AND STERILE LOT RECORD REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT AND SERIAL NUMBER WERE NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    APPROX 3 WEEKS FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION (DONE ON (B)(6) 2011) THE PT PRESENTED TO THE EMERGENCY ROOM (ER) WITH "VAGINAL BLEEDING (CLOTS), A MODEST DROP IN PCV [PACKED CELL VOLUME], MILD UTERINE TENDERNESS WITH NO PERITONEAL SIGNS, NO GI [GASTROINTESTINAL] COMPLAINTS, AND A LEUCOCYTOSIS. HER WBC [WHITE BLOOD CELL COUNT] WAS 24K [THOUSAND]". AN ULTRASOUND AND COMPUTED TOMOGRAPHY (CT) SCAN WERE "WITHIN NORMAL LIMITS". SHE WAS AFEBRILE AND VITAL SIGNS (VS) WERE STABLE. THE PT WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH "POSSIBLE ENDOMYOMETRITIS". TREATMENT INCLUDED INTRAVENOUS CLINDAMYCIN AND PENICILLIN (PCN), AND ORAL LO OVRAL (ETHINYL ESTRADIOL AND NORGESTREL) FOR BLEEDING. SHE WAS "MUCH IMPROVED" THE NEXT DAY. THE PT WAS DISCHARGED HOME 2-3 DAYS AFTER ADMISSION, ON A 7-10 DAY COURSE OR ORAL ANTIBIOTICS. ON (B)(6) 2011 THE PHYSICIAN REPORTED THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNKNOWN