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 2019-10-02 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical.
| Report Number | 3011423170-2019-00100 |
| MDR Report Key | 9145556 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-08-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-09-04 |
| Date Added to Maude | 2019-10-02 |
| 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 | JENNIFER GAMET |
| Manufacturer Street | 1400 GOODMAN STREET NORTH |
| 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 WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRAXEL RE:STORE LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2019-10-02 |
| Model Number | SYS-SR1500-D-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | 11720 N CREEK PARKWAY N STE 10 BOTHELL WA 98011 US 98011 |
| Product Code | --- |
| Date Received | 2019-10-02 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-02 |