MAUDE Adverse Event Report: MONA LISA TOUCH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Itching Sensation (1943); Pain (1994); Scarring (2061)

Event Date 07/29/2017

Event Type  Injury  

Event Description

The mona lisa touch was used for the second time.Although my vaginal area was irritated and itchy, the dr still did the treatment.It resulted in more pain and scarring.I now have even more painful intercourse and ongoing discomfort in my vaginal area.

• Brand Name: MONA LISA TOUCH
• Type of Device: MONA LISA
• MDR Report Key: 7743115
• MDR Text Key: 116044768
• Report Number: MW5078829
• 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: 07/30/2018

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 48