MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE CPT SYSTEM; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TTNS3.00E4-900

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 01/27/2022

Event Type  Injury  

Event Description

A report was received of a patient burn that was experienced during a thermage cpt treatment on the right side of the face.It was reported that the patient was given a topical anesthetic and underwent a treatment at maximum power level of 5.0 on the entire face.Additionally the treating clinic reported using enough coupling fluid, and inspecting the treatment tip prior to use as well as every 50-80 reps during treatment.No abnormalities were noted on inspection.783 reps into the treatment, while performing a pass on the right cheek, the patient complained of strong pain and reported a burning smell.The doctor noted linear erythema with edema forming immediately on the right cheek.The procedure stopped and treatment was started with ice compress, hydrocortisone butyrate cream, and growth factor gel.The patient reported to a hospital the next day and scabs were seen on the same area.Clinical photos were received which show inflammation and burn immediately after the procedure.

Manufacturer Narrative

Treatment tip has been received at evaluation site but not yet evaluated.A review of the device manufacturing record is underway.Based on available information no cause is established and no conclusions drawn.

Manufacturer Narrative

Treatment tip and system log evaluation was completed.System logs indicated the system and hand piece performed as expected.Treatment tip passed all testing, visual inspection, and functional evaluation.A review of the manufacturing records showed all requirements were met.Customer reported no system error, and nothing out of the ordinary occurred during treatment.Evaluation of the treatment tip found no issues related to this event.Burns, blisters, and scabbing are all known possible adverse patient reactions to thermage treatment.This event was most likely unrelated to the device.Based on the available information we conclude burns, blisters, and scabbing are all known possible adverse patient reactions to thermage treatment.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 98011
• MDR Report Key: 13980681
• MDR Text Key: 288688992
• Report Number: 3011423170-2022-00034
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN TOPICAL ANESTHETIC
• Patient Outcome(s): Required Intervention
• Patient Sex: Male