MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-14 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical Inc..
[127128561]
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. The exception to this would be if the fraxel tip plastic housing or component scratched the patient. For other reported events, 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. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[127128562]
The user facility reported that a patient treated with the fraxel system on the chest experienced a yeast infection 2 days later. The nature of the injury was itchy, fiery red with tiny white pustules. The patient was treated with diflucan and antibiotic. There was no permanent damage or scarring and the patient is happy with her fraxel results. Nothing out of the ordinary was observed during the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00115 |
| MDR Report Key | 8069680 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-24 |
| Device Manufacturer Date | 2015-09-25 |
| Date Added to Maude | 2018-11-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 SUITE 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 | 2018-11-14 |
| Model Number | SYS-SR1500-D-US |
| 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 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |