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U.S. Department of Health and Human Services

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

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DEKA / EL. EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH POWERED LASER SURGICAL INSTRUMENT Back to Search Results
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.

 
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Brand NameMONA LISA TOUCH
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
DEKA / EL. EN. ELECTRONIC ENGINEERING SPA
MDR Report Key7797154
Report NumberMW5079224
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 08/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/17/2018 Patient Sequence Number: 1
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