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

Model Number TTNS0.25NB1-225

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

Patient Problems Burn(s) (1757); Pain (1994); Blister (4537)

Event Date 08/05/2022

Event Type  Injury  

Event Description

A user facility reported that a day after a thermage cpt treatment, a patient experienced pain under their eye.The doctor examined the patient three days after the procedure and observed a blister that had broken under their eye.The patient''s current status is a blister and it is unknown if there will be any permanent scarring.The highest energy level during treatment was 2.0.Approximately 30ml of 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 50 pulses during the treatment with no abnormalities noted.

Manufacturer Narrative

The treatment tip was discarded by the customer and is unavailable for return.The datacard logs were returned for an evaluation.The datacard log showed errors occurred during the treatment.Error indicates a recoverable problem that requires an operator intervention.If the error occurs during a radiofrequency treatment, the radiofrequency delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.Burns, blisters, scabbing, and scarring are all known possible adverse patient reactions to a thermage treatment.The 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.A review of the manufacturing records showed all of the 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 were found related to this complaint when reviewing the device history record.Based on the available information, no causal factors can be determined and no conclusions can be drawn.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: 15351480
• MDR Text Key: 299211467
• Report Number: 3011423170-2022-00114
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS0.25NB1-225
• Device Catalogue Number: TTNS0.25NB1-225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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 Sex: Female