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THERMI THERMIVA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994)
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 Name
Type of Device
Manufacturer (Section D)
MDR Report Key5771984
MDR Text Key48863352
Report NumberMW5063234
Device Sequence Number1
Product Code GEI
Number of Events Reported1
Summary Report (Y/N)N
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;