BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE

    MDR report key: 3840211 · Received May 22, 2014

    Report

    Report Number
    MW5036345
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD NOVASURE DONE IN (B)(6) 2013. NOW, IN (B)(6) 2014, I AM EXPERIENCING INCAPACITATING PAIN, SPORADIC AND HEAVY BLEEDING. I HAVE BEEN TOLD I HAVE POST-ABLATION SYNDROME, AND I AM FACING A HYSTERECTOMY AS THE ONLY SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304496 NOVASURE NOVASURE MNB HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other