BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3021555 · Received March 13, 2013

    Report

    Report Number
    1222780-2013-00046
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 11, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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 RECORD 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 EVENT: 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 FOLLOWING A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2013 THE PATIENT BEGAN TO HAVE PAIN THE NEXT DAY AND WAS ADMITTED TO THE HOSPITAL THE FOLLOWING DAY, ON (B)(6) 2013. ON (B)(6) 2013, IT WAS REPORTED HER WHITE BLOOD CELL (WBC) COUNT WAS 15,00, NO CULTURES WERE TAKEN. THE PHYSICIAN "BELIEVES SHE HAS SOME SORT OF INFECTION" AND TREATMENT INCLUDED INTRAVENOUS (IV) ANTIBIOTICS (MEDICATION UNKNOWN). THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106209 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12B02RA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R RADIO FREQUENCY CONTROLLER: SERIAL NUMBER - UNK