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

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Date 09/10/2023

Event Type  Injury  

Event Description

A patient in china reported experiencing facial burns during a thermage cpt treatment.A topical anesthesia was applied to the patient¿s face thirty minutes prior to the thermage treatment.The patient reported that half of his face was burned, and the provider notified the patient but did not stop the treatment.The patient requested that the treatment be stopped and afterwards identified that his whole face was burned.During the treatment, the equipment was making jamming, noise, and vibration sounds.The patient was treated with a cold compress and scald ointment.The patient went to the hospital on the day of the treatment with grade ii burns and was there told not to apply the unknown scald ointment.The patient had not had any other treatments performed in the same area where the symptoms were reported and none had been performed within 30 days.Sufficient tf-3 solta medical coupling fluid and cryogen were used during the treatment.

Manufacturer Narrative

The product has not been returned for evaluation.Additional information has been requested, but not yet received the investigation is underway.

Manufacturer Narrative

Based on the received information, the reported hospital is not a customer of solta medical.As such, we are unable to collect additional information or have the product returned.Datalogs are not available for review.The serial number remains unknown, and therefore it is not possible to review the device history record.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.According to thermage cpt user manual 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.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.Trending will be performed to monitor this issue.No corrective action is necessary at this time.

Manufacturer Narrative

Further investigation is underway.

Event Description

Solta medical has confirmed that this procedure was performed by a non-certified doctor at a non-certified institution.Because the doctor and institution are not customers of solta medical, it is not likely additional information will be received.

• Brand Name: THERMAGE CPT SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• 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: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 17916200
• MDR Text Key: 325426551
• Report Number: 3011423170-2023-00086
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male