BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 5248778 · Received November 24, 2015

    Report

    Report Number
    1222780-2015-00207
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    May 26, 2014
    Report Date
    October 26, 2015
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. REFERENCE INTERNAL COMPLAINT CC#(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON MAUDE EVENT REPORT MW5056502 A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ABLATION (EXACT DATE UNKNOWN). "SIX WEEKS POST ABLATION [THE PATIENT] 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". NO OTHER ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776376 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC, INC NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RADIO FREQUENCY CONTROLLER - UNK