BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2200788 · Received July 29, 2011

    Report

    Report Number
    1222780-2011-00139
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    October 10, 2010
    Report Date
    June 29, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER AS IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED SHE "HAS BEEN BLEEDING HEAVY SINCE HAVING THE NOVASURE PROCEDURE DONE, HAD A BLOOD TRANSFUSION AND IS STILL BLEEDING". THE DATE OF THE NOVASURE PROCEDURE FOR ENDOMETRIAL ABLATION WAS REPORTED TO BE (B)(6) 2010. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNK