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

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

Patient Problems Pain (1994); Urinary Frequency (2275); Inadequate Pain Relief (2388)

Event Date 03/12/2018

Event Type  Injury  

Event Description

I had 4 treatments of mona lisa touch for vaginal rejuvenation (laser treatment), for painful intercourse and frequent urination.My symptoms got worse and intercourse more painful than before.

• Brand Name: MONA LISA TOUCH LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): HOLOGIC / CYNOSURE
• MDR Report Key: 7813039
• MDR Text Key: 118298094
• Report Number: MW5079365
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 58