BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONA LISA

    MDR report key: 10619513 · Received October 1, 2020

    Report

    Report Number
    MW5097028
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    June 1, 2016
    Report Date
    September 29, 2020
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS ADVISED THAT I COULD ALLEVIATE MY ISSUE OF VAGINAL ATROPHY (WHICH WAS CAUSED BY TAKING FEMERA FOR ESTROGEN FED BREAST CANCER), WITH THE MONA LISA DEVICE. I SAW DR. (B)(6) IN (B)(6) FOR THE MONA LISA TREATMENT. AFTER 6 TREATMENTS WITH THE MONA LISA DEVICE, MY SYMPTOMS OF VAGINAL DRYNESS AND PAIN WERE NO BETTER. I NOW HAVE SCAR TISSUE FROM THE MONA LISA WHICH HAS MADE MY VAGINAL DRYNESS AND SHRINKAGE WORSE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075735 MONA LISA POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability