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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYNOSURE, INC. MONA LISA LASER POWERED LASER SURGICAL INSTRUMENT

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CYNOSURE, INC. MONA LISA LASER POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Event Date 07/18/2017
Event Type  Injury  
Event Description

I had the mona lisa procedure performed. After the second treatment, a week later i had severe vaginal burning and severe bladder burning. One year later, i still get bladder burning and occasional vaginal burning. I am reporting this because i have seen a lot of (b)(6) comments about this procedure.

 
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Brand NameMONA LISA LASER
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
CYNOSURE, INC.
MDR Report Key7880748
Report NumberMW5079840
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 09/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2018
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

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