MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-11-06 for CLEAR + BRILLIANT LASER SYSTEM CB-CONSOLE manufactured by Solta Medical Inc..
[165418408]
Additional information has been requested but not received. A review of the device history records is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[165418409]
A physicians office reported a staph infection developed on the left cheek of a patient following a full face clear and brilliant laser treatment. The doctor reported that the patient underwent a clear and brilliant treatment across the face at a maximum energy level of high, and that the patient tolerated it well. No event codes or errors were noted during treatment. Three days post treatment the patient indicated that they had a small pimple on the left cheek that was itchy. The patient visited their general practitioner in the following days who visually diagnosed the patient with a staph infection. Following up, the treating physician took swabs and confirmed the staph infection. The general practitioner prescribed staphylex and bactroban to treat the infection. The patients current condition is fully healed from the infection with some redness to the skin still evident. It is unknown whether any permanent scarring will form, however, the treating physician deemed scarring as unlikely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00106 |
| MDR Report Key | 9286359 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-11-06 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-09-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-11-04 |
| Date Added to Maude | 2019-11-06 |
| 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. JENNIFER GAMET |
| Manufacturer Street | 1400 N GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | SOLTA MEDICAL |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL 98011 |
| 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 | 2019-11-06 |
| Model Number | CB-CONSOLE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL INC. |
| Manufacturer Address | 11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Product Code | --- |
| Date Received | 2019-11-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-06 |