BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE

    MDR report key: 9824445 · Received March 11, 2020

    Report

    Report Number
    MW5093703
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    December 16, 2019
    Report Date
    March 9, 2020
    Manufacturer
    HOLOGIC, 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

    NOVASURE ABLATION IN 2013 DUE TO EXTREMELY CYCLIC PAIN AND HEAVY BLEEDING. PREVIOUS TUBAL LITIGATION IN 2007, WHICH SHOULD HAVE EXCLUDED ME FROM HAVING THE ABLATION. BLEEDING STOPPED (SPOTTING ONLY) WITH ABLATION AND ALL WAS GOOD UNTIL 2015, AGAIN I WAS HIT WITH PAINFUL CYCLIC PAIN AND HEAVIER SPOTTING. THIS WOULD OCCUR EVERY FEW MONTHS. ON (B)(6) 2018 HAD CYCLIC PAIN AND MORE BLEEDING, THEN NOTHING UNTIL (B)(6) 2019, WHEN I HAD HEAVIER SPOTTING AND EXTREME PAIN. ON (B)(6) 2019 I AWAKENED TO BLEEDING AND EXTREME PAIN IN MY PELVIC AREA MORE ON THE LEFT SIDE. PAIN CONTINUES TO GET WORSE UNTIL I HAVE NO OTHER ALTERNATIVE THAN TO GO TO THE EMERGENCY ROOM DUE TO EXTREME LABOR LIKE PAINS THAT AFFECTED MY LOWER BACK, PELVIC AREA MORE ON THE LEFT SIDE AND MY LEFT HIP AND LEG AREA. WAS GIVEN MORPHINE WHICH ONLY DULLED THE PAIN. WAS RELEASED AND PAIN CONTINUED FOR 3 DAYS AND BROWNISH SPOTTING FOR MOE THAN A WEEK. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278837 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR