BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 920615 · Received September 26, 2007

    Report

    Report Number
    1222780-2007-00029
    Event Type
    Injury
    Date Received
    September 26, 2007
    Date of Event
    August 24, 2007
    Report Date
    August 28, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO CYTYC SURGICAL PRODUCTS, THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, AN INVESTIGATION OR REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE WAS NOT ABLE TO BE PERFORMED. NO FURTHER INFORMATION COULD BE OBTAINED THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED WITHIN 24 HOURS FOLLOWING AN UNEVENTFUL UTERINE ABLATION USING THE NOVASURE SYSTEM, THE PATIENT WAS ADMITTED WITH COMPLAINT OF CHILLS, FEVER, PAIN AND FATIGUE. THE PATIENT WAS DISCHARGED WITHIN 36 HOURS AND WAS RE-ADMITTED 24 HOURS LATER WITH BILATERAL ATYPICAL PNEUMONIA. ANTIBIOTIC TREATMENT WAS GIVEN FOR GROUP B STREPTOCOCCUS AND DISCHARGED WITH NO FURTHER TREATMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention