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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMIGEN LLC THERMI

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THERMIGEN LLC THERMI Back to Search Results
Event Date 03/29/2018
Event Type  Injury  
Event Description

I had a thermiva vaginal rejuvenation treatment by dr. (b)(6), the (b)(6) center for pelvic medicine in (b)(6). It was painful and dr. (b)(6) had to stop several times during the procedure due to this pain. Afterwards i had severe cramping for two weeks. Her associate, dr. (b)(6) then prescribed medication, installations, to try and relieve the cramping, pain, and increased bladder issues associated with the treatment. None of the procedures or meds worked. In fact, i ended up with a bladder infection from the multiple installations/catheter procedures which required antibiotic treatments. I then sought treatment relief from symptoms through pelvic floor physical therapy in (b)(6) at (b)(6) which was not covered under my (b)(6) insurance. In addition, i purchased supplements to aid my condition, also not covered by insurance. In may, i returned to (b)(6) and continued pelvic floor pt with (b)(6), hospital. After 12 weeks of treatment (b)(6) was able to relieve my bladder issues, but i am still having bowel issues related to the original treatment and will be seeing my gastro doctor this week. I have not felt well since the treatment on (b)(6) 2018 and the first thermiva treatment which cost (b)(6), of which i only received (b)(6) back to cover the wand that were not used. Dr. (b)(6) received payment for all of the treatments after thermiva from my insurance and was willing to forgive half of my co-pay. I had a history of interstitial cystitis which had not been active in three years and required no treatment until the thermiva procedure. Dr. (b)(6) noted to me that i had a history of ic, but it was in remission at the time of the treatment. I was told before the treatment that there would be no pain, no side affects. None of that was true. When i developed complications the doctors kept saying that they had never had a patient who experienced my symptoms. Dr. (b)(6) is a spokes person for the company and trains other doctors to use it. I am so sorry that i had the procedure done. I have suffered since the procedure, not to mention my life has been disrupted by all of the medical treatments i have had to alleviate the symptoms and i am not done yet. In addition, this has cost my time and money that i will never recover.

 
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Brand NameTHERMI
Type of DeviceTHERMI
Manufacturer (Section D)
THERMIGEN LLC
MDR Report Key7805369
Report NumberMW5079285
Device Sequence Number1
Product CodeGEI
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 08/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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

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