MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-09-06 for CLEAR + BRILLIANT LASER SYSTEM CB-HP-1927 manufactured by Solta Medical.
[119436729]
No additional information has been received. The product identification information has not been provided by the user facility. The device has not been returned for evaluation. Additional information has been requested from the reporter, who indicates that she is out of the country for some time and will reply on her return.
Patient Sequence No: 1, Text Type: N, H10
[119436730]
A user facility in (b)(6) reported that a patient developed blisters on the hand one day after a clear + brilliant laser treatment. Additional information has been requested. No additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00090 |
| MDR Report Key | 7852361 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-17 |
| Date Added to Maude | 2018-09-06 |
| 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 |
| 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 | 2018-09-06 |
| Model Number | CB-HP-1927 |
| Device Availability | * |
| 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 PARKWAY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |