MAUDE Adverse Event Report: DEKA MONA LISA TOUCH LASER

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

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.

• Brand Name: MONA LISA TOUCH LASER
• Type of Device: MONA LISA TOUCH LASER
• Manufacturer (Section D): DEKA
• MDR Report Key: 5658696
• MDR Text Key: 45403763
• Report Number: MW5062264
• Device Sequence Number: 1
• Product Code: GEX
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 59