MAUDE Adverse Event Report: MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cyst(s) (1800)

Event Date 06/18/2018

Event Type  No Answer Provided  

Event Description

On (b)(6) 2018 i had my first of a series of 3 laser vaginal rejuvenation done.Then on (b)(6) 2018 i had the second of 3 done.About 18 days approx after my second treatment, i discovered a vaginal lump.On (b)(6) i am seen by my pcp and the diagnosed me with having a bartholin cyst.I mentioned that i was having laser vaginal rejuvenation and she said that it possibly could produce the cyst.After that incident my 3rd treatment was scheduled for (b)(6) 2018 which i called to reschedule and later i was contacted by (b)(6) that all procedures were cancelled due to a fda warning.

• Brand Name: MONA LISA TOUCH
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• MDR Report Key: 7772703
• MDR Text Key: 117000839
• Report Number: MW5079051
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 78