MAUDE Adverse Event Report: SOLTA MEDICAL INC THERMAGE CPT SYSTEM TIP; 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); Blister (4537)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

The treatment tip has been discarded and is not available to return for evaluation.Data logs have been reviewed and the handpiece and system performed as expected.The plant evaluation is underway.

Event Description

The husband of the patient who was treated at a user facility, had reported his wife had received burns and blisters on her lower face and neck following a thermage procedure.The user facility later confirmed the injury had occurred and provided additional information.The patient did not have any other treatments performed that day and had not received any other treatments within the last 30 days, in the same symptom area.She was not given any pain medication or anesthetic at the time of the treatment.The burns and blisters appeared at the completion of treatment on the patient''s upper neck and bilateral part of the face.The patient was then given platelet-rich plasma (prp) therapy and prescribed mupirocin gel and scar gel.Currently the patient¿s condition is improving, with minor residual blistering on the upper neck, and there is no anticipation of permanent scarring.The highest energy level used was 4.5 as the patient had reported feeling minimal treatment at the lower levels of 3.0 to 3.5.Solta medical cryogen and a quarter bottle of coupling fluid were used during the procedure.This was the first time the treatment tip was used on a patient and it was inspected prior to use and throughout the procedure with no discrepancies found.It was observed during treatment on the patient¿s upper neck, that an error occurred with the return pad connection.The patient was sat up to check the return pad, which was still connected, and the return pad cable was reseated as a precaution.After reseating the return pad cable, the error did not occur again.There is no evidence at this time the return pad error led to the patient injury.

Manufacturer Narrative

The data card was returned for evaluation.The data log showed several errors had occurred during treatment.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency (rf) treatment, the rf 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.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data errors that occurred during this treatment are customer technique related.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial/lot number.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Based on the available information, no causal factors and no conclusions could be determined.According to thermage cpt system technical user¿s manual, burns and blisters, are known possible patient reaction to thermage cpt treatment.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.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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 pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 13870342
• MDR Text Key: 288690072
• Report Number: 3011423170-2022-00026
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Patient Sex: Female