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

Model Number TTNS3.00E4-1200

Device Problems Dent in Material (2526); Material Deformation (2976)

Patient Problems Burn(s) (1757); Erythema (1840); Scarring (2061)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Product evaluation showed that the tip passed flow and thermistor testing.The tip failed the leak test and visual inspection.A dent and corner damage were observed, though the cause and timing of the dent and corner damage are unknown.It is unlikely that dents and corner damage can contribute to this complaint.

Event Description

A physician¿s office reported that the patient experienced a burn on the face, following a thermage treatment.The available images were reviewed.The first image showed erythema, inflammation, and blisters on the right cheek and temporal area.In the second and third images, the blisters are resolved and hyperpigmented areas remain.The patient stated that there is scarring.The patient was treated with ice, hydrocortisone, desonide, and hydroquinone.The highest level of energy used was 3.5.The treatment tip was inspected prior to the treatment, without any abnormalities noted.The treatment tip was inspected after each treatment area.During the treatment of the right cheek, an abnormal sound was noted after about 300 reps, prompting an inspection of the tip.At this time, the treatment tip appeared abnormal.This was the first time this tip was used.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.Based on the evaluation of the data log, the handpiece and system performed as expected during this treatment.There were a large number of technique issues discovered during treatment.These errors most likely did not cause this event.Service confirmed damage on the tip membrane.Based on the available information, the patient burns were most likely caused by the corner damage on the tip membrane.It is unknown how the damage to the treatment tip occurred.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n; ste 100; bothell WA 98011
• MDR Report Key: 10200035
• MDR Text Key: 197097193
• Report Number: 3011423170-2020-00052
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention