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 2018-05-04 for FRAXEL RE:STORE LASER SYSTEM MCSR1500-D-INTL manufactured by Solta Medical, Inc..
[107327348]
The burn paper test results have been requested yet not received.
Patient Sequence No: 1, Text Type: N, H10
[107327349]
The patient received a full face treatment on (b)(6) 2018. During the treatment there were no errors and nothing out of the ordinary. On (b)(6) 2018 the patient noticed erythema residual scabbing. Additional information has been requested, yet not received, regarding the patient's current status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00036 |
| MDR Report Key | 7486364 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-05-04 |
| 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 | MRS. 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 | FRAXEL RE:STORE LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-05-04 |
| 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 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-04 |