BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONA LISA TOUCH

    MDR report key: 16701548 · Received April 6, 2023

    Report

    Report Number
    MW5116447
    Event Type
    Other
    Date Received
    April 6, 2023
    Report Date
    April 4, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD THE MONA LISA TOUCH PROCEDURE PERFORMED THREE TIMES. I DIDN'T HAVE ANY ADVERSE EFFECTS, PER SE, EXCEPT FOR THE PAIN WHILE HAVING THE PROCEDURE DONE. I AM FILLING OUT THIS FORM BECAUSE THE FDA NEEDS TO STOP DOCTORS FROM USING THIS DEVICE FOR VAGINAL ATROPHY. I SPENT (B)(6) AND GOT ZERO PERCENT RELIEF OF VAGINAL ATROPHY. GYNECOLOGICAL OFFICES ARE USING THIS DEVICE AS A HUGE MONEY MAKER AT THEIR PATIENTS' EXPENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518543 MONA LISA TOUCH POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female