MAUDE Adverse Event Report: THERMIGEN LLC THERMIVA; SYMPHONY RF GENERAL

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/15/2018

Event Type  Injury  

Event Description

Chronic pain after having thermiva treatment completed.

• Brand Name: THERMIVA
• Type of Device: SYMPHONY RF GENERAL
• Manufacturer (Section D): THERMIGEN LLC
• MDR Report Key: 7742636
• MDR Text Key: 115977322
• Report Number: MW5078784
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 52