BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3230035 · Received July 12, 2013

    Report

    Report Number
    1222780-2013-00130
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. 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 REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. 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. REFERENCE INTERNAL COMPLAINT CC NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH A FEVER OF 102 DEGREES FAHRENHEIT. THE PATIENT'S "PELVIC AND ABDOMINAL EXAMINATION WERE BOTH NEGATIVE." THE PATIENT HAD AN ELEVATED WHITE BLOOD CELL (WBC) COUNT AND WAS "STARTED ON INTRAVENOUS ANTIBIOTICS FOR PRESUMED ENDOMETRITIS." THE PATIENT'S TEMPERATURE CONTINUED TO ELEVATE DESPITE ANTIBIOTIC THERAPY. BLOOD CULTURES RETURNED POSITIVE, ORGANISM UNKNOWN. A HYSTERECTOMY WAS DONE. "WHEN THE UTERUS WAS REMOVED AND EXAMINED, THERE WAS EVIDENCE OF PURULENT MATERIAL WITHIN THE UTERINE CAVITY." "THE BLOOD CULTURE ULTIMATELY WAS POSITIVE FOR GROUP B STREPTOCOCCUS" AND "POST-OPERATIVELY, THE PATIENT HAS DONE WELL WITH COMPLETE RECOVERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324129 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R RADIO FREQUENCY CONTROLLER: SN UNK