MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-14 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-D-US manufactured by Solta Medical Inc..
[136115967]
A review of the lot manufacturing records is in progress. The device was not returned. 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 did not perform requested burn paper test and thus proper pattern/coverage cannot be verified.
Patient Sequence No: 1, Text Type: N, H10
[136115968]
A doctor reported that the patient had prolonged healing which led to facial nerve swelling and decreased lip movement. Follow up with the doctor confirmed the patient was treated on (b)(6) 2019 on their full face. The doctor used the 1550 wavelength energy 70mj, tx level #7, 2 passes; energy 50mj, tx level #7, 4 passes. A total of 6 passes to the lower face. No system errors and nothing out of the ordinary occurred during the treatment. When the patient returned on (b)(6), they had immobility of the upper lip and was not able to smile. The doctor confirmed the patient had nerve damage in the nasal labial fold causing paralysis, edema and prolonged healing. The patient was treated with a warm compress, gentle massage, hivamat treatment on (b)(6), deep oscillation and injection of vitamin b12 in the right arm. They were instructed to repeat the b12 supplements every day. Between (b)(6) there was no visible difference with the paralysis; however, there was a reduction of edema. Available pictures were reviewed. No apparent swelling or edema is visible in the pictures labeled as before and after the procedure. The doctor confirmed they do not expect any permanent damage or scarring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00013 |
| MDR Report Key | 8338615 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-14 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-08 |
| Device Manufacturer Date | 2009-10-14 |
| Date Added to Maude | 2019-02-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE CT INDUSTRIAL BLVD |
| 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 | 2019-02-14 |
| 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 | 1. Other | 2019-02-14 |