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

Model Number UNKNOWN

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

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

The tip was discarded and unable to be evaluated.The data logs were retrieved and based on the evaluation of the data, the handpiece and system performed as expected.The errors that occurred during treatment are user technique related.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition.Errors indicate 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.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.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.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is required.

Event Description

A patient reported to the 400 hotline that there were small blisters and burns on her face and neck on the second day of a thermage cpt treatment.The patient was treated with a cold compress to help alleviate symptoms.The user facility reports that the patient was administered surface anesthesia to the face for 30 minutes.It is also reported that the patient''s current status is a first-degree burn of the lower face and neck and that no permanent damage or scarring is expected.However, photos of the patient''s face were sent in and reviewed by the medical reviewer.The medical reviewer deemed this case as serious as the pictures contradict the reported first-degree burns.The pictures demonstrated multiple large blisters visible on one side of the face and neck area.The other side of the face presented with small blisters and erythema.No other treatments (besides thermage) were being performed in same area where the symptoms were reported, and the patient has not undergone any other treatments in the same symptom area within the past 30 days.It is reported that this event may have occurred at around 800 reps on left and right side of the face and 200 reps on the right side of neck.The highest energy level used was 2.0 - 4.0 on the face and 1.5 -2.0 on the neck.No system errors occurred, nor was anything out of the ordinary during treatment.Solta medical croygen and coupling fluid used during this treatment.The treatment tip surface was inspected prior to use and the tip film was flat without damage.The treatment tip surface was inspected during the treatment at about every 100 reps and this was the first time the tip was used.It is reported that the patient has recovered and refused to provide additional photos.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 16824461
• MDR Text Key: 314104280
• Report Number: 3011423170-2023-00045
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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