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

Model Number TTNS0.25NB1-450

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Skin Discoloration (2074); Swelling/ Edema (4577)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

Treatment tip and data logs are not available for evaluation.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A patient reported a burn on their eyelid after a thermage treatment.The patient was placed under topical anesthesia during the treatment.Ice compresses and desonide cream was administered to the patient immediately post treatment.The physician noted a burn immediately following the treatment on the right upper eyelid.The second day after the treatment the patient noticed edema in the left lower eyelid.Five days later after the patient returned to the hospital, the physician also noted both the right upper eyelid and left lower eyelid had scabbing.The patient was treated with a growth factor.It is unknown if there will be any permanent scarring.The available picture was reviewed and post inflammatory hyperpigmented is seen under the eyelid.The incident occurred at approximately 225 reps for each eye.The highest energy level used was 3.5 for right eyelid and 3.0 for left eyelid.It was reported that enough amount of cryogen fluid was used and no error messages were observed.The tip was inspected before and during the treatment at every 150 reps and no issues were noted.

Manufacturer Narrative

Product is not available for evaluation.It was reported the tip was inspected prior and during treatment and no system errors or anything out of the ordinary was noted.According to the thermage cpt user manual burns, blister, and scabbing are known possible reactions to treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.Based on the available information, no causal factors can be determined and no conclusions can be drawn.

• Brand Name: THERMAGE CPT SYSTEM
• 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; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman street north; rochester, NY 14609
• MDR Report Key: 12367539
• MDR Text Key: 268138747
• Report Number: 3011423170-2021-00093
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female