MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-16 for CLEAR + BRILLIANT LASER SYSTEM UNKNOWN manufactured by Solta Medical.
[127391310]
The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[127391311]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00113 |
| MDR Report Key | 8078257 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-17 |
| Date Added to Maude | 2018-11-16 |
| 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 MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-11-16 |
| Model Number | UNKNOWN |
| 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. Required No Informationntervention | 2018-11-16 |