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

Model Number CB-HP-1927

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Skin Discoloration (2074); Blister (4537)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The device history record showed the final test verification specifications to be acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The clear+brilliant treatment tips do not delivery any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.The exception to this would be if the clear+brilliant tip plastic housing or component scratched the patient.For other reported events, tips are not a viable source of evaluation data.System has no system/data logs that can be reviewed.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.Customer performed burn paper test and sent it to product support for review.Review of burn paper showed proper pattern/coverage.The patient was prescribed fucidin h; their current status is that they have hyperpigmentation on the hand.The investigation is ongoing.

Event Description

The user facility in (b)(6) reports chin blisters, pustules, and hand hyperpigmentation occurring on a patient following a clear & brilliant procedure of the hands and face.

Manufacturer Narrative

The device history record was reviewed.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.According to clear+brilliant treatment (p009341-03 rev.A), discoloration is known possible complication of treatment.The possibility of temporary and permanent skin color change is known to exist with any laser treatment.Post-inflammatory hypo-pigmentation and hyper-pigmentation are known complications of many laser treatments and may occur with clear+ brilliant laser treatment.Following appropriate instructions for sun protection will lower the risk for pigmentation changes.A review of manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Based on the available information, discoloration is known possible complication of treatment.The root cause is a known procedure complication.The investigation is complete.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek pkwy n, ste 100; bothell WA 98011
• MDR Report Key: 12214906
• MDR Text Key: 264538821
• Report Number: 3011423170-2021-00066
• 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
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CB-HP-1927
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention