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
• 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

• 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 Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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 Outcome(s): Required Intervention