BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONALISA TOUCH LASER

    MDR report key: 13634811 · Received February 28, 2022

    Report

    Report Number
    MW5107794
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    February 4, 2022
    Report Date
    February 28, 2022
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD MONA LISA TOUCH PROCEDURE IMMEDIATELY FELT IRRITATION DURING THE PROCEDURE TO THE VAGINAL CANAL AND LABIAS. WAS TOLD BY THE DOCTOR THAT IT WAS NORMAL AND TO EXPECT TO FEEL DISCOMFORT FOR A FEW HOURS. DISCOMFORT, IRRITATION AND PAIN IS ONGOING SINCE THE PROCEDURE. REPORTER STATES SHE WAS BURNED AND WAS GIVEN AQUAPHOR, STEROIDAL CREAM AND COLLOIDAL SILVER OVER THE COUNTER FOR TREATMENT. NONE OF THOSE TOPICAL CREAMS ARE PROVIDING RELIEF TO THE DISCOMFORT AND IRRITATION THAT SHE FEELS. REPORTER STATES THAT SHE RESEARCHED ON (B)(6) PRIOR TO THE PROCEDURE AND COULD NOT FIND ANY COMPLAINTS BUT ONE SEEN ON AN ATTORNEYS SITE. SHE DOES NOT WANT ANYONE ELSE TO GO THROUGH WHAT SHE IS FEELING AND DOES NOT WANT THE MONA LISA LASER TO RECEIVED APPROVAL FROM THE FDA FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303196 MONALISA TOUCH LASER POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O AQUAPHOR| COLLOIDAL SILVER CREAM| STEROIDAL CREAM