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

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

Patient Problems Burn(s) (1757); Scar Tissue (2060); Skin Discoloration (2074)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Additional product information has been requested, but not received.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

It was reported by a patient that one day post thermage facial treatment she developed blisters and scars.She did not receive any medical treatment.Follow up with the treating physician indicates that the patient was given topical anesthetics during the treatment.It was reported nothing out of the ordinary occurred at that time.The physician sent tranexamic acid as a medical treatment to the patient, however they have not been able to make contact with the patient.Patient photos were provided, one hyperpigmented lesion on the left cheek and three hyperpigmented lesions on the right cheek were observed.

Manufacturer Narrative

Product was discarded.Data logs were evaluated, based on the evaluation of the data, the treatment tip, the handpiece and system performed as expected.The review of the data logs indicate the treatment tip is suspected to not be a solta manufactured product.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

According to thermage cpt system technical user¿s manual burns, blisters, scabbing, and scarring are known possible patient reaction to 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.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.No system errors or anything out of the ordinary were reported to have occurred during treatment.No product was returned to be evaluated.No lot number was provided, therefore no manufacturing records could be reviewed.Evaluation of data logs, showed the handpiece and system performed as expected.This issue was most likely unrelated to the device.Based on the available information, no causal factors can be determined and no conclusions can be drawn.

• 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: 10328045
• MDR Text Key: 200599815
• Report Number: 3011423170-2020-00060
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN TOPICAL ANESTHETIC
• Patient Outcome(s): Other