BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONA LISA TOUCH

    MDR report key: 16487308 · Received March 2, 2023

    Report

    Report Number
    MW5115431
    Event Type
    Injury
    Date Received
    March 2, 2023
    Report Date
    February 28, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MONA LISA TOUCH PROCEDURE WAS DONE IN 2018. I WAS LEFT WITH SERIOUS BURNS AND PERMANENT SCARRING. DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705914 MONA LISA TOUCH POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other LEXAPRO 20 | SPIROLACTONE 100| XANAX 1MG