MAUDE Adverse Event Report: CYNOSURE MONA LISA TOUCH LASER TREATMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/09/2017

Event Type  Injury  

Event Description

Caller had the mona lisa touch laser procedure for a treatment for the painful symptoms of intimacy.She started this treatment in (b)(6) 2017 and had three treatments that are six wks apart.She stated it cost (b)(6) and out of pocket but the treatment did not work.She is still experiencing painful intercourse.Caller went back to the dr to complain about the non therapeutic effect and was advised to continue to use the post procedural cream but that did not work either.

• Brand Name: MONA LISA TOUCH LASER TREATMENT
• Type of Device: MONA LISA TOUCH LASER TREATMENT
• Manufacturer (Section D): CYNOSURE
• MDR Report Key: 7738936
• MDR Text Key: 115774296
• Report Number: MW5078724
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 102