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 2019-05-10 for CLEAR + BRILLIANT LASER SYSTEM CB-CONSOLE manufactured by Solta Medical.
[144725016]
Additional medical information and product serial number were requested, however the doctors office did not wish to provide further detail in regards to the event. Treatment tips do not deliver any energy and no treatment data is stored on the tip itself; there is no information to gather from their return. 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. Doctors can also utilize the burn paper to confirm system laser is providing correct pattern/ coverage. The doctor did not perform requested burn paper test and thus the manufacturer cannot verify proper pattern/coverage. 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
[144725017]
It was reported by a doctor? S office that after treatment, a patient exhibited erythema and small scattered pin point bleeding in their face. It is unclear how far after the treatment, the erythema and pin point bleeding occurred. Photos were obtained and they confirmed that pin point bleeding is visible. A company clinical specialist reached out to the office, and they informed the office this typically happens when multiple treatments are spaced too close together instead of 4 weeks apart. Additional medical information was requested, however the doctor? S office stated they did not wish to provide further information in regard to the event as the patient? Is fine?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00056 |
| MDR Report Key | 8600405 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-13 |
| Device Manufacturer Date | 2015-03-31 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| 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 | 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 | 2019-05-10 |
| Model Number | CB-CONSOLE |
| Operator | HEALTH PROFESSIONAL |
| 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 NORTH CREEK PKWY SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-10 |