BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPENDANCE CONTROLLED EA SYSTEM

    MDR report key: 3902180 · Received June 19, 2014

    Report

    Report Number
    1222780-2014-00095
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 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 AND STERILE LOT REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014. APPROXIMATELY 24 HOURS POST PROCEDURE, THE PATIENT CONTACTED THE PHYSICIAN COMPLAINING OF CHILLS AND FEVER OF 103 DEGREES FAHRENHEIT. THE PHYSICIAN RECOMMENDED THE PATIENT RETURN TO THE EMERGENCY ROOM (ER). CULTURES WERE TAKEN AND REVEALED ESCHERICHIA COLI PRESENT REPRESENTING BOWEL BACTERIA IN THE BLOOD. UPON OBSERVATION, THE PHYSICIAN MENTIONED THE UTERUS IS NOT "MUSHY" AND PUS IS FOUND IN THE ABDOMEN. THE PHYSICIAN CONFIRMED NO PERFORATION OF THE UTERUS. THE PATIENT WAS UNDER OBSERVATION AND WAS EXPECTED TO BE RELEASED ON (B)(6) 2014. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360780 NOVASURE IMPENDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

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