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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 03/31/2016
Type of Reportable Event Serious Injury
Event or Problem 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 Name
MONA LISA TOUCH LASER
Common Device Name
MONA LISA TOUCH LASER
Manufacturer (Section D)
DEKA
MDR Report Key5658696
Report NumberMW5062264
Device Sequence Number15243726
Product Code GEX
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 05/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/12/2016
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age64 YR
Patient Weight59
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