MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-05 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical Inc.
[137874952]
Product has not been returned. Additional event information has been requested, but not received. 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
[137874953]
A physician office representative reported that the patient developed blisters on their temple post treatment. Additional event information has been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00028 |
| MDR Report Key | 8392004 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-05 |
| Date of Report | 2019-02-07 |
| Device Manufacturer Date | 2010-03-24 |
| Date Added to Maude | 2019-03-05 |
| 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 CT INDUSTRIAL BLVD |
| 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 | FRAXEL RE:STORE LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2019-03-05 |
| Model Number | SYS-SR1500-D-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-05 |