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

Model Number TTNS3.00E4-1200

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

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

Event Date 10/02/2021

Event Type  Injury  

Event Description

A patient reported by phone that they experienced blistering on their right cheek during a thermage cpt face and neck treatment.The treatment details were collected from the treating clinic.The doctor reported that prior to treatment the patient was treated with an unidentified topical anesthetic and that the treatment tip was inspected with no abnormalities observed.During treatment the tip was inspected every 100 reps and the highest treatment level was 4.0.The doctor reported using enough coupling fluid throughout the treatment.At 550 reps the doctor noted blisters on the right cheek.The treatment tip was changed and the treatment was completed without issue.Following treatment the doctor gave an unidentified burn ointment.Upon initial report the patient status was noted as 1-2 small pits in the burn area.Available pictures were reviewed by a medical reviewer.Post inflammatory hyperpigmented lesions are visible scattered over the right cheek and upper neck area.Current patient status is reported as only slight hyperpigmentation remaining in the burn area.

Manufacturer Narrative

Treatment tip was discarded following treatment and is not available for evaluation.Based on available information no conclusion can be drawn and no root cause can be established.

Manufacturer Narrative

Evaluation of system logs has been completed.Evaluation noted that they found the hand piece serial number did not match with the serial number reported on the case, however the handpiece performed as expected during treatment.Thermage systems have software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.It was also noted there were two treatments on (b)(6) 2021.The reporter did not specify during which treatment time period the event occurred, therefore both treatment data logs were evaluated, and in both cases it was concluded that the system, hand piece, and treatment tip performed as expected.The treatment tip is not available for evaluation because it was discarded.Based on all currently available information in this case, no cause can yet be established and no conclusion can be drawn.

Manufacturer Narrative

Correction to section h10 component code.Previous component code 484 changed to 4755.Burns and blisters are known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual states the procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.The treatment tip was not returned for evaluation, but evaluation of the data showed the system, handpiece and the tip performed as expected.No tip was returned for evaluation so no visual inspection was performed.Based on the available information, no causal factors can be determined and no conclusion can be drawn.

• 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 14609
• MDR Report Key: 12764197
• MDR Text Key: 280474084
• Report Number: 3011423170-2021-00125
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female