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 2018-11-02 for CLEAR + BRILLIANT LASER SYSTEM CB-CONSOLE manufactured by Solta Medical.
[125921050]
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 investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[125921051]
A patient received a clear_brilliant permea treatment to the entire face on (b)(6) 2018 on a medium energy level. The patient claims a hyaluronic acid filler injected underneath the eyes has lessened the c+b permea treatment. The filler was injected twelve days prior to the (b)(6) treatment by a different clinic not affiliated with this doctor. On (b)(6) 2018 using a high energy level the patient elected to have a follow up c+b permea treatment and dr. (b)(6) injected additional hyaluronic acid filler. The patient has not responded to multiple follow-up attempts by the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00108 |
| MDR Report Key | 8032350 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-08-17 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2018-11-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR + BRILLIANT LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAR |
| Product Code | ONG |
| Date Received | 2018-11-02 |
| Model Number | CB-CONSOLE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | 11720 N. CREEK PRKW N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-02 |