MAUDE Adverse Event Report: THERMIGEN, LLC THERMIVA; ELECTROSURGICAL, CUTTING & COAGULATION

Device Problem Use of Device Problem (1670)

Patient Problems Nerve Damage (1979); Deformity/ Disfigurement (2360); Numbness (2415)

Event Date 10/12/2016

Event Type  Injury  

Event Description

I was asked by a dr to come in and try a vaginal device.I did 2 treatment with thermiva (radiofrequency) and everything was ok, however, the 3rd procedure left with vaginal numbness.I did not have any vaginal issues before this procedure.I am a young and healthy (b)(6) y/o left with vaginal numbness.I have since tried prp injections to help with very little benefit.The neurologist told me it was nerve damage from the laser.Not only do i have numbness i am also left with vaginal disfigurement.This has been the worst experience of my life.I am not able to get pregnant either and not sure if this has anything to do with it.

• Brand Name: THERMIVA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION
• Manufacturer (Section D): THERMIGEN, LLC
• MDR Report Key: 7818945
• MDR Text Key: 118431391
• Report Number: MW5079424
• Device Sequence Number: 0
• Product Code: GEI
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 59