BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1931163 · Received December 9, 2010

    Report

    Report Number
    1222780-2010-00191
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 OF THE DISPOSABLE NOVASURE DEVICE IS NOT KNOWN. UTERINE FLUID. THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYSTEM CANNOT BE COMPLETED. LOT NUMBER IS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MANUFACTURE DATE OF THE DISPOSABLE DEVICE IS NOT KNOWN. 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 REC'D, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    APPROX ONE TO TWO YEARS FOLLOWING A NOVASURE ENDOMETRIAL ABLATION PROCEDURE, THE PT PRESENTED WITH "SEVERE CYCLIC PAIN". AN ULTRASOUND INDICATED A "SMALL AMOUNT OF FLUID IN THE [UTERINE] CAVITY" AND THE PHYSICIAN PERFORMED A DILATION. THE PT REPORTEDLY HAD "RELIEF AFTER DILATION". 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER - SERIAL # UNK