MAUDE Adverse Event Report: DEKA / EL. EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Irritation (1941); Pain (1994)

Event Date 03/28/2018

Event Type  Injury  

Event Description

I was told by my urologist, dr (b)(6) that i would be a good candidate for the mona lisa touch procedure because i experienced vaginal dryness and pain during intercourse.Since i tend to have reactions to topical estrogen, this seemed like a good option for me.There seemed to be no adverse side effects except right after the procedure.It was a series of 3 laser treatments performed (b)(6) 2017, (b)(6) 2018, and (b)(6) 2018.I expressed my concern after the first treatment, but they encouraged me by saying perhaps my symptoms would improve with the next 2 treatments.But instead after the 3rd treatment, i was not able to have sexual intercourse at all, plus my urinary frequency got worse.Since the last procedure, i have been to the university of (b)(6) where i was diagnosed with a yeast infection, lichen sclerosis, dyspareunia, atrophic vaginitis.I now have a chronic condition of pain in the vaginal area that has ruined my sex life with my husband.The women's health dept has been treating me since (b)(6) 2018.It is unk how long it will take to heal the cuts and skin irritation, along with all the diagnosed items that i believe were, caused or made worse by these laser treatments.I am now scheduled for pelvic floor therapy to begin (b)(6) 2018.

• Brand Name: MONA LISA TOUCH
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): DEKA / EL. EN. ELECTRONIC ENGINEERING SPA
• MDR Report Key: 7797154
• MDR Text Key: 117709197
• Report Number: MW5079224
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 56