BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONA LISA TOUCH

    MDR report key: 11613055 · Received April 2, 2021

    Report

    Report Number
    MW5100533
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    July 16, 2019
    Report Date
    March 31, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS TREATED BY A MONA LISA LASER TOUCH DEVICE FOR VAGINAL REJUVENATION AND I SUSTAINED PERMANENT DISABLING INJURY FROM THE DEVICE. I BEGAN A 3 COURSE TREATMENT. THE FIRST TWO WERE DONE BY DR. (B)(6) IN (B)(6) 2019. I DID NOT HAVE ANY PAIN AT THAT TIME. I THEN CHANGED DOCTORS AND WENT TO DR. (B)(6) FOR THE FINAL TREATMENT ON (B)(6) 2019. I THEN IMMEDIATELY BEGAN HAVING SEVERE PAIN, BURNING, AND NERVE PAIN. I WAS DIAGNOSED BY DR. (B)(6) WITH PADENAL NEURALGIA AND VULVODYNIA. I AM CURRENTLY IN PAIN MANAGEMENT AND HAVE GOTTEN NO RELIEF FROM MY INJURY. I AM UNABLE TO SOME NORMAL DAY TO DAY ACTIVITIES AS A RESULT OF MY PERMANENT INJURY AND ONGOING PAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508982 MONA LISA TOUCH POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| S