BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3143060 · Received May 23, 2013

    Report

    Report Number
    1222780-2013-00097
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. STERILE LOT RECORD WAS REVIEWED FOR THIS DISPOSABLE DEVICE AND WAS CONFIRMED TO BE WITHIN SPECIFIED LIMITS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION AND THE PATIENT WAS DISCHARGE HOME. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE ABDOMINAL PAIN AND TACHYCARDIA. THE PHYSICIAN PERFORMED A LAPAROSCOPY AND "NO PERFORATION OR BOWEL INJURY" WAS NOTED. THE PATIENT'S BLOOD WORK REVEALED A "HIGH WHITE BLOOD CELL (WBC) COUNT OF 37.66". THE PATIENT WAS ADMITTED ON (B)(6) 2013 AND DISCHARGED ON (B)(6) 2013 WITH A "NORMAL WBC OF 10.60". ON (B)(6) 2013, THE PHYSICIAN'S NURSE REPORTED THE "PATIENT IS DOING FINE". ON (B)(6) 2013, THE PHYSICIAN'S NURSE REPORTED THE PATIENT'S URINE CULTURE EXHIBITED "(B)(6)". NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229959 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12L15R

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNKNOWN