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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bruise/Contusion (1754); Pain (1994)
Date of Event 06/06/2016
Type of Reportable Event Serious Injury
Event or Problem 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
THERMIVA
Common Device Name
THERMIVA
Manufacturer (Section D)
THERMI
MDR Report Key5771984
Report NumberMW5063234
Device Sequence Number16580705
Product Code GEI
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 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
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/30/2016
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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