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

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient reported that one day post thermage treatment they developed swelling, redness, and blisters.Additional information has been requested but not yet received.

Manufacturer Narrative

Additional medical and product information was requested, but not received.Product was not returned for evaluation.Burns, blisters, redness, and swelling are all known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual states 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 factor can be determined and no conclusion 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: 10684815
• MDR Text Key: 213205178
• Report Number: 3011423170-2020-00094
• 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
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other