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
• 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

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 32 YR
• Patient Weight: 59
• Patient Outcome(s): Other; Required Intervention