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

Model Number TTNS0.25NB1-450

Device Problems Improper or Incorrect Procedure or Method (2017); Dent in Material (2526); Insufficient Information (3190)

Patient Problems Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician¿s office reported that a patient experienced blisters on their face and neck after undergoing a laser treatment.Two days post treatment the blisters broke open and began to scab, the patient also experienced hyperpigmentation.The reporting office did not want to provide any additional information regarding this event.

Manufacturer Narrative

Corrected d3 and d4.The product and datacard logs were returned and an evaluation was completed.Treatment tip passed flow, leak and thermistor tests.Functional testing was not performed as the tip was expired.The tip failed visual inspection as a dent in the tips membrane surface was observed.However, it is not possible to determine when and how the dent occurred.It is unlikely that dents can contribute to the related complaint.No dielectric breakdown was observed.The datacard logs evaluation found there was no issue found with the tip related to the event.The data logs were able to confirmed an error which indicates tip to warm and under force errors.The service evaluation found a large amount of user technique issues that occurred during treatment; such as, under force errors that resulted in inadequate cooling and led to unsafe treating conditions.A review of the manufacturing records showed all requirements were met.According to thermage cpt system technical user¿s manual burns, blisters, scabbing, and hyperpigmentation are known possible patient reactions to the thermage treatment.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.Based on all the available information, this event was most likely caused by user technique issues.

Manufacturer Narrative

Corrected b3 date of event.The product has been requested but not yet received.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional medical information was received from the physician¿s office.The office confirmed that the patient experienced second degree burns on their face and neck after undergoing a thermage treatment.Topical anesthetics were used on the patient prior to treatment.The patient was advised to treat the burn with an ice compress and then apply an ointment to the affected area.The patient is currently experiencing hyperpigmentation in the burnt area.Available images have been reviewed and hyperpigmented lesions are visible on both cheeks and under the neck.It is unknown at this time if there will be permanent damage or scarring.During the procedure an error of tip too warm appeared.This was the first time the treatment tip was used.The tip was inspected prior to treatment and nothing unusual was noted.The tip was not inspected throughout the treatment.

• 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: 9512402
• MDR Text Key: 182200901
• Report Number: 3011423170-2019-00122
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS0.25NB1-450
• Device Catalogue Number: TTNS3.00E4-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• 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: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention