BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1853328 · Received September 30, 2010

    Report

    Report Number
    1222780-2010-00141
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXP 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) AND STERILE LOT RECORDS REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS IDENTIFICATION NUMBERS 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

    IT WAS REPORTED THAT A PATIENT RETURNED TO THE PHYSICIAN'S OFFICE WITH "ABDOMINAL BLOATING AND BLEEDING" 5 WEEKS FOLLOWING A NOVASURE ABLATION PROCEDURE. THE PATIENT HAD A SONOGRAM IN THE EMERGENCY ROOM (ER), DATE UNK, AND THE ENDOMETRIAL LINING WAS REPORTED TO BE 1.4 MM. THE PHYSICIAN REPORTED A "BIOPSY CONFIRMED ENDOMETRITIS" FOR WHICH ANTIBIOTICS WERE GIVEN. NO ADD'L TREATMENT WAS PERFORMED. ON (B)(6)2010, THE PHYSICIAN REPORTED THE PATIENT HAS NOT RETURNED FOR HER F/U APPOINTMENT AND HAS NOT CALLED THE OFFICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNKNOWN