BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 10250945 · Received July 9, 2020

    Report

    Report Number
    1222780-2020-00097
    Event Type
    Injury
    Date Received
    July 9, 2020
    Report Date
    June 24, 2020
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL AND LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED UNDER MW FORM # 5093703. IT WAS REPORTED BY THE PATIENT THAT ON AN UNKNOWN DATE IN 2013, SHE HAD AN ENDOMETRIAL ABLATION PROCEDURE. SINCE THE ABLATION, SHE HAS REPEATEDLY EXPERIENCED HEAVY, CYCLIC PAIN AND "HEAVIER SPOTTING." IN 2019, SHE REPORTED TO THE ER WITH LABOR LIKE PAINS IN HER LOWER BACK IN PELVIC AREA. THIS PAIN WAS ACCOMPANIED WITH "BROWNISH" SPOTTING FOR OVER A WEEK. NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716020 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O