MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-12-03 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-INTL manufactured by Solta Medical.
[129077270]
The product was not returned for evaluation. Final test verification specifications are acceptable. No non-conformities or anomalies were found related to this complaint when reviewing the device history record for serial/lot number (b)(4), manufacturing date: 03/21/2007. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[129077271]
A user facility in (b)(4) reported that a patient experienced blisters and erythema on the left and median lumbar region 1-2 hours after a fraxel re:store treatment. It was reported that 10cm2 of the body was treated. Wavelength 1500 was used, energy 70mj, level 7/20%, 8 passes. No system errors occurred and nothing out of the ordinary was observed during the treatment. This was the third use of the treatment tip and no burn test was performed prior to using the tip. The customer states that the system and handpiece had recently been repaired. Secondary intervention was necessary, including evacuation of the blister fluid, cortisone ointment, and cicaplast cream. The patient has no lingering symptoms and there will be no permanent damage or scarring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00120 |
| MDR Report Key | 8125640 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-03 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-24 |
| Date Added to Maude | 2018-12-03 |
| 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 | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal | 98011 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | BAUSCH + LOMB, INC |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 |
| 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 | 2018-12-03 |
| Model Number | SYS-SR1500-INTL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-03 |