MAUDE Adverse Event Report: SOLTA MEDICAL, INC CLEAR + BRILLIANT LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Model Number CB-CONSOLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

The customer reported no system errors and nothing out of the ordinary occurred during treatment.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.The customer performed a burn paper test and sent it in for review.The review of the burn paper showed proper pattern/coverage.According to clear+brilliant user manual and system hazard analysis, burns are known possible complications of treatment.Pattern paper testing showed the system was providing proper pattern/coverage during treatment.A review of the manufacturing records showed all requirements were met.The manufacturing records show final test verification specifications are acceptable.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates based on the available information, burns are known possible reaction to clear+brilliant treatment.No capa is required for this event.

Event Description

A user facility reported that a patient experienced post treatment affects from a clear + brilliant procedure to the face.The patient experienced the normal redness and a hot sensation a few hours after treatment.Later that evening, the patient''s skin began to feel painful, to which the patient applied ice.The next morning, the patient had large red rashes on the majority of her face that were oozing and bleeding.The medical director at the user facility diagnosed this as a burn.The patient was prescribed an anti-inflammatory topical, and an oral antibiotic to prevent infection.Available pictures were reviewed by the solta medical reviewer.Skin burns with inflammation and redness are visible on both cheeks, perioral area, chin, and with lesser degrees on the nose and forehead areas.This case was marked as serious by the medical reviewer.This incident occurred at 4 passes with the highest energy level used as a 2.No issues were reported concerning the device in question.The current status concerning the patient is that they are healing, without the expectation of permanent damage.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 16480300
• MDR Text Key: 310635023
• Report Number: 3011423170-2023-00029
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CB-CONSOLE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1