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 Problem Blister (4537)

Event Date 02/05/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested.The investigation is underway.

Event Description

A user facility reported blisters on a patient''s lower face post thermage treatment.No secondary intervention was required to treat this event.It is reported that there is the possibility of scarring.No other treatments (besides thermage) were being performed in same area where symptoms were reported and the patient did not undergo any other treatments in the same symptom area within the past 30 days.The patient received 1200 pulses and the highest energy level used was 3.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta cryogen and national brand ultrasound gel were used.The treatment tip surface was inspected prior to use and nothing was noted.The treatment tip surface was re-inspected during the treatment at about every 500 pulses.This is the first time the treatment tip was used.

Manufacturer Narrative

The product has been requested.The investigation is underway.

Event Description

A user facility reported blisters on a patient''s lower face post thermage treatment.No secondary intervention was required to treat this event.It is reported that there is the possibility of scarring.No other treatments (besides thermage) were being performed in same area where symptoms were reported and the patient did not undergo any other treatments in the same symptom area within the past 30 days.The patient received 1200 pulses and the highest energy level used was 3.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta cryogen and national brand ultrasound gel were used.The treatment tip surface was inspected prior to use and nothing was noted.The treatment tip surface was re-inspected during the treatment at about every 500 pulses.This is the first time the treatment tip was used.

Manufacturer Narrative

The product was returned and evaluated.The tip first was used for 1200 treatments.The tip passed the flow, leak and thermistor test.The tip failed the visual inspection, as there was a black dot/blemish.No dielectric breakdown was observed.The plant evaluation is underway.

Manufacturer Narrative

The treatment tip and datacard logs were returned for evaluation.Evaluation of the treatment tip found no issues related to this event.Based on the evaluation of the data, the handpiece and system performed as expected.Based on the available information, burns and blisters are a known possible reaction to thermage cpt treatment.Evaluation of the datacard log showed errors occurred during treatment.Error indicates a recoverable problem that requires 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.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, the handpiece and system performed as expected.According to thermage cpt system technical user¿s manual (p009240-06 rev a), burns and blisters are a known possible reaction to 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.A review of 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.Trending will be performed to monitor this issue.No further action is required at this time.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Complaint type identified within risk analysis and performing within anticipated rate no corrective action is required.

• 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 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 13525689
• MDR Text Key: 286010375
• Report Number: 3011423170-2022-00012
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1