BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1945572 · Received December 10, 2010

    Report

    Report Number
    1222780-2010-00196
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    October 10, 2010
    Report Date
    November 12, 2010
    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 DEVICE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE 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 AND SERIAL NUMBER WERE NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION TOOK PLACE ON (B)(6)2010 FOLLOWED BY A "PELVIC INFECTION". ON (B)(6) 2010, THE PT PRESENTED WITH LOWER ABDOMINAL PAIN AND VAGINAL DISCHARGE AND WAS ADMITTED TO THE HOSPITAL. LAB WORK, AN ULTRASOUND, AND A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WERE PERFORMED WITH FINDINGS OF ESCHERICHIA COLI IN THE URINE. THE PT WAS TREATED WITH ANTIBIOTICS AND DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT WAS SEEN ON F/U AND WAS "BETTER". WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE PELVIC INFECTION.

    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 41 YR Other RADIO FREQUENCY CONTROLLER - SERIAL # UNK