MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-27 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical.
[101058137]
The fraxel treatment tips do not deliver any energy and no treatment data is stored on the tip itself; there is no information to gather from their return. Tips are not a viable source of evaluation data. System has no system/data logs that can be reviewed. System has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits. Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage. Customer performed burn paper test and sent it to product support for review. Review of burn paper showed proper pattern/coverage. Dhr-final test verification specifications are acceptable. No non-conformity's or anomalies found related to this complaint when reviewing the device history record for serial/lot number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101058138]
The user facility noticed the day after treatment, redness and breakout of whiteheads at the right temple and forehead, near hairline on side of face. Eye shield lubrication was used. There were no other treatments performed in this area. The 1927 wavelength was the highest energy level used, with range of reps/sites 10j/tl, 4/8 passes. The treatment tip was used twice before, burn test was performed when tip was opened and nothing appeared odd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00015 |
| MDR Report Key | 7299787 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-27 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2012-12-20 |
| Date Added to Maude | 2018-02-27 |
| 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. 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 | 2018-02-27 |
| Model Number | SYS-SR1500-D-US |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 STE100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-27 |