MAUDE Adverse Event Report: THERMIGEN, LLC THERMIVA; ELECTROSURGICAL, CUTTING AND COAGULATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 09/18/2018

Event Type  Injury  

Event Description

Pt is experiencing symptoms from having a series of vaginal rejuvenation treatments.She began her first treatment on (b)(6) 2018 in which she seemed fine until she had her second treatment on (b)(6) 2018.Her gynecologist stated "it looks worse than when you first came in," which worried the pt.The pt described feeling discomfort on her right side during the treatment and believed the device was on the highest level of frequency.Her last treatment was done on (b)(6) 2018, where she describes her vaginal area as fiery red, sensitive to touch and very painful.She also reports her vaginal area being dry as well as a burning sensation while showering with soap.The pt was seen by two dermatologists, who believe she received vaginal burns from the treatment.She is being treated with vaginal estrogen cream until her dr sees any improvements.The pt is worried she may have issues that are life-long and may never be sexually active again.

• Brand Name: THERMIVA
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION
• Manufacturer (Section D): THERMIGEN, LLC
• MDR Report Key: 8587412
• MDR Text Key: 144459238
• Report Number: MW5086429
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 54