BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASUREZ IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION

    MDR report key: 3193516 · Received June 20, 2013

    Report

    Report Number
    MW5030678
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    NOVACEPT, INC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2009, A LOCAL (B)(6) HOSP PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON MY UTERUS, AFTER I WAS DIAGNOSED WITH ANEMIA AND MENORRHAGIA, DUE TO POLYPOS/FIBROIDS NOTED IN VAGINAL ULTRASOUNDS. MY CYCLE SLOWLY RETURNED AFTER THE SURGERY, ABOUT 2 YRS LATER, IN 2011 WITH LITTLE EFFECTS NOTED. LAST YR, IN (B)(6) 2012, I BEGAN TO HAVE SEVERE CRAMPS THAT WERE WORSE WITH THE INGESTION OF COFFEE. IN (B)(6) 2013, I BEGAN TO HAVE CRAMPS SO SEVERE DYSMENORRHEA THAT I NEARLY PASSED OUT WHILE DRIVING. I WAS SEEN BY ER PHYSICIANS IN (B)(6) 2013 AND TWICE AGAIN IN (B)(6) 2013 FOR THE SAME SYMPTOMS: MENSTRUAL CRAMPS RADIATING DOWN INTO MY LEGS, OVARIES, LOWER FRONT PELVIC AREAS THAT COULD NOT BE CONTROLLED BY OTC NSAIDS, CODEINE/TYLENOL, TORADOL SP, AND OXYCODONE/TYLENOL. I CAN NOT STAND, WALK, SPEAK, OR SAFELY OPERATE A MOTOR VEHICLE WHEN THESE CRAMPS HIT IN TIMING WITH MY CYCLE, WHICH HAS RETURNED SOME MONTHS AND DISAPPEARED AT OTHERS. MY CERVIX IS PRESUMED TO BE BLOCKED BY SCAR TISSUE FROM THIS PROCEDURES AND IT IS PRESUMED THAT I AM SUFFERING FROM HEMATOMETRA, ENDOMETRIOSIS, AND CERVICAL STENOSIS. WE ARE STILL CURRENTLY IN THE DIAGNOSIS STAGE, WHILE USING BIRTH CONTROL PILLS TO REGULATE MY CYCLE INTO NOT EVEN OCCURRING IN THE NEXT TWO MONTHS. IT APPEARS I AM HEADED FOR A HYSTERECTOMY AS I WAIT FOR MY CONSULT WITH A LOCAL WOMENS CLINIC. THE (B)(6) IS ALSO ACTIVELY TRYING TO MANAGE THIS CONDITION, WHICH WAS REPORTED TO THEM IN (B)(6) 2013. THEY HAVE BEEN SLOW TO ADDRESS THESE SYMPTOMS, IN SPITE OF THE ER VISITS, WHICH LED TO MY SEEKING OUT A SECOND OPINION WITH A LOCAL CLINIC WITH BETTER CREDENTIALS AND STAFFING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281485 NOVASUREZ IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION NOVASURE MNB NOVACEPT, INC UNK, NAVY

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L NOVASURE ENDOMETRIAL ABLATION