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 2017-12-27 for FRAXEL RE:STORE DUAL LASER SYSTEM MCSR1500-D-INTL manufactured by Solta Medical Inc..
[95896653]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[95896654]
It was reported that after a facial treatment, the patient suffered burns on the face. It was also reported that the treatment was ineffective for hyperpigmentation of the skin. Additional information for this event was requested but was not received.
Patient Sequence No: 1, Text Type: D, B5
[109253987]
The device was not returned for evaluation. Device history records were reviewed and not discrepancies or anomalies were found. In the risk analysis for the laser treatment, burns are identified as a known possible complication of the treatment and was deemed acceptable. Additional attempts to collect more information regarding this event were unsuccessful. Based on available information, the root cause of this event cannot be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011423170-2017-00073 |
| MDR Report Key | 7150343 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-14 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2013-02-22 |
| Date Added to Maude | 2017-12-27 |
| 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. FARANAK GOMAROONI |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985708 |
| 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 | FRAXEL RE:STORE DUAL LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2017-12-27 |
| Model Number | MCSR1500-D-INTL |
| ID Number | NI |
| 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 INC. |
| Manufacturer Address | 11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-27 |