BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANE CONTROLLED EA SYSTEM

    MDR report key: 3161569 · Received May 6, 2013

    Report

    Report Number
    1222780-2013-00103
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    January 2, 2013
    Report Date
    May 7, 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 DEVICES ARE NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MFR DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. THERE WERE NO ABNORMALITIES NOTED. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE NOVASURE DEVICE OR THS HYSTEROSCOPY EQUIPMENT AS PRODUCT IDENTIFICATION NUMBERS WERE 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. (B)(4).

    Description of Event or Problem · 1

    A NOVASURE ENDOMETRIAL ABLATION WAS PERFORMED ON (B)(6) 2012. THE PT RETURNED TO THE DOCTOR'S OFFICE ON (B)(6) 2013 WITH "MALAISE AND THICK, FOUL SMELLING, DISCHARGE FROM THE CERVIX AND VAGINA". ADDITIONALLY, "SHE HAD SORES ON HER BUTTOCKS FROM THE DISCHARGE". SHE WAS DIAGNOSED WITH "POSSIBLE ENDOMETRITIS". TREATMENT INCLUDED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) AND FLAGYL (METRONIDAZOLE). NO CULTURES WERE DONE AND THE PATIENT WAS NOT ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197740 NOVASURE IMPEDANE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER: SERIAL # (B)(4)| THS HYSTEROSCOPE: SERIAL # UNK| THS HYSTEROSCOPE SHEATH: SERIAL NUMBER UNK