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U.S. Department of Health and Human Services

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

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THERMIGEN, LLC THERMIVA ELECTROSURGICAL, CUTTING & COAGULATION Back to Search Results
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.
 
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Brand NameTHERMIVA
Type of DeviceELECTROSURGICAL, CUTTING & COAGULATION
Manufacturer (Section D)
THERMIGEN, LLC
MDR Report Key7818945
MDR Text Key118431391
Report NumberMW5079424
Device Sequence Number0
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/24/2018
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 Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
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