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 2019-02-01 for FRAXEL RE:STORE LASER SYSTEM TT4.00F6-900 manufactured by Solta Medical.
[134880487]
The data log information was uploaded on january 15, 2019. Based on the evaluation of the data the handpiece and the system performed as expected. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[134880488]
Blisters appeared on the patients cheeks twenty minutes after a thermage fraxel treatment to the face. The highest energy level used was 4. 0. Post treatment the patient was given a gentle cool down treatment. The blisters have subsided and there will no permanent damage or scarring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00007 |
| MDR Report Key | 8298854 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-13 |
| Date of Event | 2018-12-31 |
| Device Manufacturer Date | 2018-10-08 |
| Date Added to Maude | 2019-02-01 |
| 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 | FRAXEL RE:STORE LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-03-25 |
| Model Number | TT4.00F6-900 |
| Device Availability | R |
| 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 | 1. Other | 2019-02-01 |