MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-10 for CLEAR + BRILLIANT LASER SYSTEM CB-CONSOLE manufactured by Solta Medical.
[150594131]
Additional medical information was requested, but not received. Entire system was not returned for evaluation. However the handpiece utilized during event was evaluated. The snout, outer upper housing and light cap was replaced. Laser was calibrated and the unit was tested for 10 consecutive minutes. All tests were passed. A review of the device history records is in progress. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[150594132]
The registered nurse from the doctors office reported during the first treatment the patient responded well with no issues on low level, 2-4 passes. Over 4 weeks later the patients had a second treatment in which they had mild discomfort so the settings were lowered. The second treatment was done on level high, 4 passes. After the second treatment the patient developed immediate redness, they used mild (b)(6) skincare products with no acids or retinols. The office instructed the patient to use hydroquinone cream to assist with the redness. The patient used this once every other day. About 4 weeks post treatment the redness turned into dark spots and post inflammatory hyperpigmentation. Available photos were reviewed showing scattered erythema and hyperpigmented lesions on the patient's face and forehead. They have been using hyaluronic acid and 6% hq for 3-4 weeks, they are still under treatment. Additional information has been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00075 |
| MDR Report Key | 8777087 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-10 |
| Date of Report | 2019-06-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-07-24 |
| Date Added to Maude | 2019-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | SOLTA MEDICAL |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR + BRILLIANT LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2019-07-10 |
| Model Number | CB-CONSOLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | 11720 NORTH CREEK PKWY SUITE 100 BOTHELL WA 98011 US 98011 |
| Product Code | --- |
| Date Received | 2019-07-10 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-10 |