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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Irritation (1941); Pain (1994)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): DEKA / EL. EN. ELECTRONIC ENGINEERING SPA
• MDR Report Key: 7797154
• Report Number: MW5079224
• Device Sequence Number: 1406514
• Product Code: GEX
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 56