BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONA LISA TOUCH LASER, A MINIMALLY INVASIVE LASER TREATMENT

    MDR report key: 8133536 · Received December 4, 2018

    Report

    Report Number
    MW5081837
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    February 17, 2018
    Report Date
    December 3, 2018
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED THE PROMISING MONA LISA TOUCH (MLT) PROCEDURE INSIDE THE VAGINA, FROM (B)(6), AND BEGAN SUFFERING FROM NEW AND EXCRUCIATING SIDE EFFECTS. I HAVE THE FOLLOWING NEW SIDE EFFECTS IN THE VAGINA: SCAR TISSUE, TEARING INFLAMMATION, UTIS, SENSITIVITY AND PRONE TO VAGINAL INFECTIONS. I AM UNABLE TO HAVE A SEXUAL RELATIONSHIP WITH MY HUSBAND AS PROMISED FROM THE NURSES AT THE MLT INTRODUCTION AND THIS HAS CREATED A LOT OF MENTAL STRESS. SEVERAL CULTURES WERE DONE BY DR NICOLE M. HOOK TO RULE OUT SIDS AND OTHER POSSIBLE DISEASE, WHICH IS IRRELEVANT AS I AM UNABLE TO PERFORM SEXUALLY AND MY HUSBAND AND I DO NOT HAVE OTHER PARTNERS. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? YES. HOW WAS IT TAKEN OR USED? VAGINAL; DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017; DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. REASON FOR USE: I WAS PROMISED QUICK AND PAINLESS RESTORED VAGINAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971464 MONA LISA TOUCH LASER, A MINIMALLY INVASIVE LASER TREATMENT POWERED LASER SURGICAL (INSTRUMENT) GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| S