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

Model Number TTNS3.00E4-1200

Device Problem Dent in Material (2526)

Patient Problems Burn(s) (1757); Erythema (1840); Inflammation (1932); Blister (4537)

Event Date 03/19/2024

Event Type  Injury  

Event Description

A user facility reported blister with a possible burn to the right side of the face during a thermage cpt treatment.Prior to the treatment, the patient was given demerol 75mg, gravol 50mg im to dg and offered a snack.Secondary intervention included a cooling pack.Available pictures were reviewed, and some pictures appear to be prior to the procedure, the pictures that appear to be after procedure shows erythema and inflammation on one side of the face.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used was 3.0j.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta medical cryogen and coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and the tip was said to be fine.The treatment tip was said to be inspected during treatment with nothing remarkable to report.However, it is reported that after the treatment, a dent was noticed in the tip.This was the first time the treatment tip was used.

Manufacturer Narrative

The product has been requested and the investigation is ongoing.

Event Description

The user facility reports that the patient is still being treated by the provider and that the patient will have scarring.

Manufacturer Narrative

The treatment tip was returned for evaluation.Evaluation of the tip showed it passed the flow, leak, and thermistor tests.Service observed a dent on the tip membrane.It is unlikely that the dent contributed to this event since radiofrequency energy was able to distribute evenly across the tip membrane.No dielectric breakdown observed.Evaluation of the tip found no issues related to this event.According to thermage cpt system technical user¿s manual, burns and blisters are known possible adverse patient reactions 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.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.If datalogs are received and reviewed, a supplemental report will be filed.The investigation is still on going.

• 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: 19125915
• MDR Text Key: 340392782
• Report Number: 3011423170-2024-00143
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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