MAUDE Adverse Event Report: THERMI GEN LLC DBA THERMI THERMITIGHT; ELECTROSURGICAL, CUTTING AND COAGULATION

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Irritation (2076)

Event Date 12/21/2017

Event Type  Injury  

Event Description

Thermitight made my chin and neck worse.I now look (b)(6).My derm of 15 years has comparison pics of before treatment and now 3 months after.I look terrible and now have a double chin which i didn't have before.My skin is wrinkled and just not smooth now due to this device.It needs to be off the market for cosmetic use.

• Brand Name: THERMITIGHT
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION
• Manufacturer (Section D): THERMI GEN LLC DBA THERMI
• MDR Report Key: 7366173
• MDR Text Key: 103519129
• Report Number: MW5076066
• 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: 03/20/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 52