BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1671923 · Received April 30, 2010

    Report

    Report Number
    1222780-2010-00062
    Event Type
    Injury
    Date Received
    April 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. SERIAL NUMBER OF RFC NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. DEVICE HISTORY AND STERILE LOT RECORDS WERE REVIEWED AND NO CONTRIBUTING FACTORS OR ABNORMALITIES WERE NOTED. CURRENTLY, UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION PROCEDURE OCCURRED ON (B) (6) 2010. APPROXIMATELY SEVEN DAYS POST-PROCEDURE, THE PATIENT COMPLAINED OF "FEVER AND MALAISE". THE PHYSICIAN REPORTED THAT THE PATIENT'S UTERUS WAS TENDER AND HE "PRESCRIBED ANTIBIOTICS TO COVER [HIS] DIAGNOSIS OF ENDOMETRITIS". WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 09G18RC

    Patients

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