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

Model Number CB-HP-1927

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

Patient Problems Anaphylactic Shock (1703); Inflammation (1932); Irritation (1941); Rash (2033); Swelling (2091)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Product will not be returned for evaluation because the clear+brilliant treatment tips do not deliver any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.System has software safeguards that will trigger error/event codes should the system be outside of acceptable limits.Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.Customer did not perform requested burn paper test and thus we cannot verify proper pattern/coverage.A review of the device history record is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that three days after undergoing a clear + brilliant treatment the patient called to report they were experiencing redness and irritation across the chest, neck, and lower face, as well as throat swelling.The patient reported they initially observed redness, puffiness, and hives in the treatment area that progressively got worse.The patient self treated with benadryl.The patient visited the emergency room on the third day and the physician indicated an anaphylactic reaction had occurred and administered the patient an oral steroid and gave the patient an epi-pen in case of additional reaction.The physician believes that the patient experienced an allergic reaction to the topical gel applied to the patient.The patient is recovered.The patient was treated with clear + brilliant across the face and neck.No issues or errors were reported during the treatment.The patient was administered a topical anesthetic prior to treatment composed of lidocaine and tetracaine hcl liposav.The doctor reported that during treatment the highest power level used was high.The doctor noted following the treatment the patient was administered over the counter topical creams skinceuticals ce ferulic and colorscience even up spf 50 on the treatment site.It was reported that the patient has a sulfa allergy.The doctor also indicated that the patient underwent an ipl treatment for rosacea in the same area around 2 weeks prior to the clear + brilliant treatment.

Manufacturer Narrative

Corrections made to sections b3.Manufacturing records showed all requirements were met.It was reported no system errors or anything out of the ordinary occurred during treatment.A medical review of this case determined device causality was unlikely in this event.Based on the available information, this event was most likely patient related and caused by reaction to topical anesthetic (non-solta product) or product applied post treatment.The current status was noted as resolved with no permanent injury.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 9699801
• MDR Text Key: 185891872
• Report Number: 3011423170-2020-00024
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K120433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CB-HP-1927
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention