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

Model Number TTNS0.25NB1-450

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Blister (4537)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

The tip was discarded and thus not available for evaluation.According to thermage flx user manual, burns, blisters, discomfort, and swelling are a known possible side effects during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause 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 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.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is necessary at this time.

Event Description

A user facility reported that a patient developed a blister on the eye bag with pain one day after a thermage cpt eye treatment.No secondary intervention was reported, and it is unknown if there will be any permanent damage or scarring.Available photographs were reviewed by the medical reviewer.The timing of the pictures is unclear.Picture 1 shows erythema on the lateral side of the upper eyelid of one eye.Picture 2 shows erythema and a blister on the interior side of the upper eyelid of one eye (probably the other eye than the first picture).Picture 3 shows mild erythema on the lateral side of the upper eyelid of one eye (probably the same eye as picture 1).No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.It is unknown if the patient has undergone any other treatments in the same symptom area within the past 30 days.The incident occurred after 450 reps and the highest energy level used was 2.0.E163 was reported during the treatment.Approximately 30 ml of coupling fluid were used during this treatment as well as solta medical croygen.The treatment tip surface was inspected prior to use and there was nothing remarkable.The treatment tip surface was inspected during the treatment at about every 50 reps.This is the first time this treatment tip was used.The treatment tip was not kept and is unavailable for a product evaluation.

Manufacturer Narrative

Correction of h10 from: according to thermage flx user manual, burns, blisters, discomfort, and swelling are a known possible side effects during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause 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.Correction of h10 to: according to thermage cpt user manual (p009240-06 rev.A) burns are a known issue.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.No treatment tip was available for evaluation.The datacard log was returned for evaluation.The datacard log was corrupted but data near the treatment date was provided.Based on the evaluation of the data, the handpiece and the system performed as expected.However, error codes: 131-136 (warning: failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition) were evident.It is recommended that the user should verify proper treatment technique, position, and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).The handpiece needs to be perpendicular to the ground at the time of the treatment.The 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.Service found errors may have been due to technique.However, these errors present no risks to the patient and would not have caused the event.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the evaluation of the data, the handpiece and system performed as expected.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.No corrective action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM AND ACCESSORIES
• 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 n 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: 16961085
• MDR Text Key: 315549528
• Report Number: 3011423170-2023-00049
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: TTNS0.25NB1-450
• Device Catalogue Number: TTNS0.25NB1-450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2023
• 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