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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

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.

• Brand Name: MONA LISA LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CYNOSURE, INC.
• MDR Report Key: 7880748
• MDR Text Key: 120635819
• Report Number: MW5079840
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 70