MAUDE Adverse Event Report: THERMI THERMIVA

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?.

• Brand Name: THERMIVA
• Type of Device: THERMIVA
• Manufacturer (Section D): THERMI
• MDR Report Key: 5771984
• MDR Text Key: 48863352
• Report Number: MW5063234
• Device Sequence Number: 1
• Product Code: GEI
• Number of Events Reported: 1
• 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 Received: 06/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention