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); Blister (4537)

Event Date 07/19/2022

Event Type  Injury  

Event Description

A user facility reported to a distributor that a patient experienced erythema and blisters on the left side of their face during a thermage cpt treatment.The doctor used an ice compress on the left cheek area and checked the treatment tip, with no abnormalities found.They proceeded to treat the neck area and erythema and blisters were observed on the neck.Treatment was then stopped and the doctor treated the patient with an ice compress to the areas, along with dexamethasone cream.The patient was given topical anesthetics prior to the procedure and the current status is scabbing in the treatment areas.The highest energy level during treatment was 4.5.Adequate coupling fluid was used during the treatment and there were no error codes during the procedure.The treatment tip was inspected prior to use, as well as every 60-70 pulses during the treatment with no abnormalities noted.

Manufacturer Narrative

The datacard log was returned for evaluation.Based on the evaluation of the data, the hand piece and system performed as expected.The treatment tip has not been returned for an evaluation yet; however, the tip has been requested to be returned.The plant evaluation is underway.

Manufacturer Narrative

Correction: e5 facility name - from: (b)(6), to: (b)(6).The treatment tip was returned and the evaluation was completed.During evaluation of the treatment tip, service found a tear on the tip membrane.The tip passed the flow test and thermistor test, but failed the leak test and visual inspection for dents on the tip surface.Functional testing was not performed due to the damage on the tip surface.The thermage user manual instructs the operator to inspect the treatment tips for any signs of physical damage prior to, during, and after treatment.With respect to all thermage systems, clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.According to thermage cpt system technical user¿s manual, burns and blisters are known possible patient reaction to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n,; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15259780
• MDR Text Key: 298234059
• Report Number: 3011423170-2022-00107
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2022

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
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention