MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE FLX (TG-3A) AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TT4.00F6-600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537); Localized Skin Lesion (4542); Hyperpigmentation (4837)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported a blister to the patient's neck one day post thermage flx treatment.An available picture was reviewed by the medical reviewer and three to four minor blisters were visible on patient's neck.The patient was treated with topical corticosteroid and the patient's current status is listed as a residual erythematous lesion.It is unknown if there be any permanent damage or scarring.No other treatments (besides the one reported) being performed in the same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days, nor has the patient ever had prior aesthetic treatments on this area.The patient was not administered any pain medication or placed under anesthesia.The incident occurred between 2-3 reps.When asking the customer if a system error or something out of the ordinary was noticed during treatment, they replied yes but did not provide details.A stamping method was used.Solta cryogen and 3/4 a bottle of solta unscented coupling fluid were used.The treatment tip surface was inspected prior to use and nothing remarkable was noted.The treatment tip surface was not inspected during the treatment.The tip used in this treatment has not been used to treat other patients or used previously.Based on the review by the medical reviewer, this case was assessed as a serious injury and deemed to be reportable.
Additional Manufacturer Narrative
The datalogs were reviewed and based on the evaluation of the data, the handpiece and system performed as expected.The device is in transit and has not been returned for an evaluation at this time.The investigation is ongoing.
Event or Problem Description
Updated information of the event includes that the patient currently has post-inflammatory hyperpigmentation.Additional available pictures were reviewed by the medical reviewer and two pictures that were noted to be taken approximately a week before this report, showed erythematous areas visible on patient's neck.
Additional Manufacturer Narrative
The treatment tip and data log were returned for evaluation.Evaluation of the treatment tip found no issues related to this event.The tip passed leak test, thermistor test, and visual inspection.No dents, scratches, blemishes, or dielectric membrane breakdown were observed.It was unknown what type of system errors occurred during the treatment.However, evaluation of the data log found that the following errors occurred during treatment: quantity - error id - description - percent of reps: 1 - e2212 - err_crit_write_check_error - 0.17%.1 - ec78b - err_treatment_tip_force_low - 0.17%.1 - ec78c - err_treatment_tip_temp_high - 0.17%.1 - ec78e - err_force_before_activation - 0.17%.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, the user needs to intervene and follow the onscreen instructions to proceed with treatment.Based on the evaluation of the data, the system and handpiece perform as expected.According to the thermage flx system user manual, blisters and hyperpigmentation are known possible side effects of 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.Hyperpigmentation usually resolves over the course of time (within several months).No nonconformities or anomalies were 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.Based on the available information, blisters and hyperpigmentation are known possible side effects of thermage flx treatment.At this time, no capa is necessary.

• Brand Name: THERMAGE FLX (TG-3A) AND ACCESSORIES
• Common Device Name: 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: 20358464
• Report Number: 3011423170-2024-00212
• Device Sequence Number: 20653984
• Product Code: GEI
• UDI-Device Identifier: 00816995021421
• UDI-Public: 00816995021421
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: TT4.00F6-600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown