BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE

    MDR report key: 5104983 · Received September 21, 2015

    Report

    Report Number
    MW5056502
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    May 26, 2014
    Report Date
    September 21, 2015
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SIX WEEKS POST-ABLATION EXPERIENCED SEVERE BURNING IN THE PUBIC BONE WITH MILD TO SEVERE CRAMPING AND LOWER BACK PAIN. IT WORSENS MID CYCLE. DURING THE TIME WHEN MENSTRUATION WOULD HAVE OCCURRED THE PAIN BECOMES SEVERE WITH CRAMPS AND BACK PAIN. IT IS NOW ACCOMPANIED BY LRQ SHARP PAIN, MIGRAINE, BLOTTING, SLUGGISH BLADDER AND BOWEL ISSUES. SEVERE ANXIETY AND DEPRESSION ACCOMPANIED BY CONTINUOUS CRYING. SHE IS UNABLE TO WORK OR PERFORM HOUSEHOLD DUTIES. SHE IS CURRENTLY SCHEDULED FOR HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623562 NOVASURE NOVASURE MNB HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other