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

Model Number UNKNOWN

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

A patient reported severe redness and painful swollen skin with burn-like streaks on the cheeks, forehead and chin twenty four hours after a third clear & brilliant treatment to the face.The patient did not have the same reaction with the previous two treatments.The patient was put under a red led light for treatment and then given dermaid and a tea-tree based product to use at home.Two days after the treatment the symptoms worsened and the clinic sent the patient to a dermatologist who prescribed "prenisolone" and ointment to use on the area.Initially the patient was taking two "prenisolone" tablets a day and then eleven days post treatment the patient contracted a secondary infection which was treated by antibiotics which were prescribed by the patients general practitioner.The patient still has some residual global redness but is improving.This event was reported by the facility that provided post-op treatment to the patient.The facility where the initial treatments occurred is unknown.

Manufacturer Narrative

The clinic has not responded to product support and no additional information was provided.The treatment tip and data logs were not provided for evaluation.It is unknown if system errors or anything out of the ordinary occurred during treatment.The events reported are all known possible complication of clear+brilliant treatment.Based on the available information, no causal factors can be determined, and no conclusion can be drawn.According to according to clear+brilliant user manual (p009341-03 rev.A) and hazard assessment (sha-09-004 rev.I) itching, dryness, and burns are possible patient responses to treatment.These are common symptoms once the skin has healed initially.Flakiness and dry crusting will gradually clear.Use of bland moisturizers and/or sunscreens that have previously been shown to not cause irritation should help this condition.Secondary infection is also a possible complication a risk of infection exists whenever the skin is wounded.The possibility for infection exists even with non-ablative fractional laser devices such as clear + brilliant.If observed, infection should be treated appropriately with topical and/or systemic medications.The serial/lot number was not reported for this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is necessary at this time.The investigation is complete due to the clinic not responding.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n. creek prkw n; suite 100; bothell WA 98011
• MDR Report Key: 8078257
• MDR Text Key: 127391310
• Report Number: 3011423170-2018-00113
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention