BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE

    MDR report key: 826517 · Received March 5, 2007

    Report

    Report Number
    MW1042118
    Event Type
    Other
    Date Received
    March 5, 2007
    Date of Event
    October 20, 2006
    Report Date
    March 5, 2007
    Manufacturer
    NOVACEPT
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD NOVASURE ENDOMETRIAL ABLATION IN 2006. AFTERWARDS I BEGAN EXPERIENCING SEVERE PAIN AND BURNING IN MY BLADDER AS WELL AS BLADDER SPASMS AND FREQUENCY. I TOOK A COURSE OF MACRODANTIN WHICH DID NOT HELP-THINKING IT WAS A BLADDER INFECTION-. MY DOCTOR THEN PRESCRIBED KEFLEX. THIS ALSO DID NOT HELP. MY DOCTOR THEN SENT MY URINE FOR A CULTURE, WHICH CAME BACK NEGATIVE. HE THEN CONCLUDED THAT THE NOVASURE DEVICE INJURED/BURNED/IRRITATED? MY BLADDER. MY DOCTOR THEN PUT ME ON A MEDICATION CALLED URELLE. I ALSO TAKE AN OVER-THE-COUNTER URINARY TRACT PAIN RELIEVER CALLED AZO STANDARD FOR RELIEF. I STILL HAVE ABDOMINAL SWELLING AND INTERMITTENT BLADDER PAIN 4 1/2 MONTHS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE * MNB NOVACEPT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other