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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEKA MONA LISA TOUCH LASER

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DEKA MONA LISA TOUCH LASER Back to Search Results
Event Date 03/31/2016
Event Type  Injury  
Event Description

On (b)(6) 2016, my gynecologist (dr. (b)(6)) performed a vaginal rejuvenation using the mona lisa touch laser which was approved for use by the fda in december of 2014. Two days after the procedure, i developed severe and debilitating bladder/urethral pain. I returned to dr. (b)(6) twice within a two week time period following the procedure and, both times, had urinalysis performed, which were negative. I consulted with a urologist, who had no idea how to treat my symptoms, as he had not heard of the mona lisa touch. Once again, negative urinalysis. I have left dr. (b)(6) practice and am under the care of a new gynecologist, who is treating me with vagifem daily (curative effects of estrogen, hopefully). My doctors and i are in the dark as to how to proceed and what i can expect as far as, once again, being pain free. There is no viable research on the internet regarding this procedure and virtually no negative comments, feedback, or threads, which leads me and my physicians to wonder if the internet is being "scrubbed" by the manufacturer. Had i had access to full disclosure, i would have chosen not to have this procedure performed. Thank you.

 
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Brand NameMONA LISA TOUCH LASER
Type of DeviceMONA LISA TOUCH LASER
Manufacturer (Section D)
DEKA
MDR Report Key5658696
Report NumberMW5062264
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation Patient
Report Date 05/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2016
Is This An Adverse Event Report? Yes
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/12/2016 Patient Sequence Number: 1
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