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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMI THERMIVA

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THERMI THERMIVA Back to Search Results
Event Date 06/06/2016
Event Type  Injury  
Event Description

Everyone is talking about vaginal rejuvenation. I was invited to a thermiva event by my friend. The sales rep told us that the product could be used for urinary incontinence. So i decided to get it done. I was in so much pain. I decided to do more research and saw that the website talks about urinary incontinence and how it can cure it. So i decided there must be something wrong with me and went to my obgyn and she then informed me that i had bruising and she looked on the fda website and told me that the product is not approved from fda. So how can they sell it?.

 
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Brand NameTHERMIVA
Type of DeviceTHERMIVA
Manufacturer (Section D)
THERMI
MDR Report Key5771984
Report NumberMW5063234
Device Sequence Number1
Product CodeGEI
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/30/2016 Patient Sequence Number: 1
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