BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONALISA TOUCH LASER

    MDR report key: 21039162 · Received December 27, 2024

    Report

    Report Number
    MW5164072
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    January 1, 2023
    Report Date
    December 21, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WENT TO DR. (B)(6) TO ADDRESS VAGINAL ATROPHY AND PAINFUL INTERCOURSE AND SHE RECOMMENDED THE MONALISA TOUCH LASER. I HAD THE THREE RECOMMENDED TREATMENTS PERFORMED AND ONCE THE PROCEDURES WERE COMPLETED I NOTICED NEW SEVERE PAIN AT MY VAGINAL OPENING AND THE LEFT SIDE OF MY INTERNAL VAGINA WALL. I REPORTED THIS NEW PAIN TO DR. (B)(6). THIS PAIN CONTINUES TO THIS DAY AND MY SPOUSE, AND I RARELY HAVE INTERCOURSE NOW DUE TO THESE NEW PAINFUL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134094 MONALISA TOUCH LASER POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female