BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONA LISA TOUCH LASER

    MDR report key: 11301204 · Received February 9, 2021

    Report

    Report Number
    MW5099296
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    July 1, 2013
    Report Date
    February 5, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS INFORMED BY MY GYNECOLOGIST THAT THE MONA LISA TOUCH WOULD HELP PREVENT UTI'S, AND PREVENT COMMON ISSUES FOR WOMEN MY AGE. AFTER COMPLETING THIS TREATMENT, MY BLADDER PAIN BECAME SO SEVERE THAT I BECAME SUICIDAL, AND NOW HAVE CONSTANT BLADDER INFECTION, INCLUDING A RESISTANT BACTERIA. MY PAIN NEVER GOES AWAY NOW. MY UROLOGIST PERFORMED A CUSTOM AND THERE IS NO LINING LEFT IN MY BLADDER, JUST A BIG RED IRRITATED MESS. I CAN NO LONGER HAVE SEX. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197981 MONA LISA TOUCH LASER POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other D MANNOSE