MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-12 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical, Inc..
[138562331]
Product? S 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; they are not a viable source of evaluation data. Additionally, the product 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 the system be outside of acceptable limits. The physician? S office reported neither any system errors nor anything out of the ordinary during treatment. Burn paper tests may also be used to confirm the system laser is providing correct pattern/coverage. Physician? S office performed burn paper test and sent it to the manufacturer for review. The burn paper tests have good differentiation in the dots between the four settings. The testing does not indicate any horizontal banding. Review of the burn paper showed proper pattern/coverage. Finally, according to the fraxel user manual (p009220-03 rev. A), burns and erythema are known possible complications of a fraxel treatment. Blistering or burns may develop over the treated areas. The possibility for scarring exists even with non-ablative fractional laser devices such fraxel. Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing. Mild-moderate transient erythema is an expected response. However, if erythema is severe or persists significantly longer than expected, re-treatment should be avoided until the condition resolves. Reactions may vary on a patient-to-patient basis. A review of the manufacturing records showed all requirements were met with no non-conformities or anomalies found when reviewing the product? S device history record. The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates. Based on all the information, blisters and erythema are known possible complications of fraxel treatment.
Patient Sequence No: 1, Text Type: N, H10
[138562332]
Physician? S office reported that patient was treated on (b)(6) 2019 and that two days post procedure the patient experienced blisters, erythema and excoriation over the forehead and temporal area. No other treatment was done on the area. The highest energy level used during the treatment was 20 mj with 8 passes. Office reported that the original treatment tip utilized had been used five times prior to the reported event but that they opened a new tip for the patient? S forehead and preauricular area. Available patient pictures were reviewed by the manufacturer and blisters, erythema and scabs are visible over the patient's face and forehead. Follow-up information obtained from the office indicates that the patient received clobetasol 0. 5% ointment for three days and v-beam to moderate the erythema. Physician? S office notes that the patient is healing and has improved greatly. As of (b)(6) 2019, office is still treating patient for erythema with v-beam. Whether a permanent scar will remain is yet to be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00033 |
| MDR Report Key | 8413306 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-11 |
| Date of Event | 2019-02-06 |
| Device Manufacturer Date | 2011-12-28 |
| Date Added to Maude | 2019-03-12 |
| 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. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | SOLTA MEDICAL, INC. |
| 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 | 2019-03-12 |
| 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 BOTHEL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-12 |