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

Model Number TTNS3.00E4-900

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Scarring (2061); Skin Discoloration (2074)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

The review of the system/data logs does not indicate there is any handpiece or system issue present.Requested treatment tip was not available for return and thus could not be evaluated.System has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.A review of the device history logs is in progress.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

An aesthetician reported that a patient experienced hyperpigmentation in the neck area six weeks post a thermage treatment over the face and neck area.The patient has had multiple treatments at this office without any issue.Patient was instructed to use obagi 4% lightening cream and recommended possible laser therapy to correct the hyperpigmentation.Available images were reviewed, hyperpigmented lesions are visible on both sides of the neck.There is a possibility of a permanent car.The highest energy level used was 3.5.No system alerts or error codes occurred during the treatment.The treatment tip was inspected before treatment and every 300 pulses after with no issues.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.Based on the evaluation of the datacard log, the handpiece and system performed as expected.The treating clinic did not observe any alerts or event codes during treatment and there were no discrepancies with the tip observed.According to thermage cpt system technical user¿s manual, pigment changes are known possible patient reaction to thermage treatment.Cases of hyperpigmentation usually resolve over the course of time.

• 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
• MDR Report Key: 9516225
• MDR Text Key: 178113043
• Report Number: 3011423170-2019-00131
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Was Device Available for Evaluation?: No
• 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: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention