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

Model Number TT0.25F6-450

Device Problem Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

The data logs and treatment tip have been requested to be returned to the manufacturer but have not yet been received.A plant evaluation is underway.

Event Description

A distributor reported that a user facility performed a thermage eye treatment and following the completion of the eye treatment, it was observed that the patient had received a burn on both eyelids.They had edema and erythema on both eyelids with the right eyelid depressed and white.Following treatment the patient had erythema and edema on both eyelids and the right lower eyelid was white and depressed.They were immediately treated with a cold compress and burn ointment.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 2.5.The treatment tip was inspected prior to use and during the treatment when an electric noise was heard.No discrepancies on the tip were found.Later that night, the patient saw there were some blisters, and the skin tone had become darker on the burn areas.The patient had not received any treatment to the same symptom area on the procedure day or within 30 days prior.The current status reported as hyperpigmented and hypopigmented lesions with unknown outcome.Pictures of the patient were reviewed, and scabs were visible on the upper and lower eyelids on both sides.

Manufacturer Narrative

The data log from the patient event has been reviewed and it showed an error code had occurred.When the system detects a condition that interrupts treatment, a system error code is displayed.The system provides an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece performed as expected the tip was returned for evaluation.Service was unable to verify reported complaint due to tip being expired.The tip passed the leak test, and passed the visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Based on the available information, no causal factors can be determined and no conclusions can be drawn.According to thermage flx system user manual burns are known possible adverse patient reactions to 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.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 14524017
• MDR Text Key: 292829692
• Report Number: 3011423170-2022-00070
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Device Catalogue Number: TT0.25F6-450
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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
• Treatment: UNKNOWN TOPICAL ANESTHETICS
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female