MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-12-04 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-US manufactured by Solta Medical.
[185889142]
A review of the device history records is in progress. The device has been requested but not yet returned for evaluation. Additional information has been requested but not yet received. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[185889143]
A patient reported that they experienced burns and hyper-pigmentation following a fraxel laser treatment on their face. The patient also reported nerve damage to an unspecified location on their face. The patient indicated that the person performing the treatment rolled the fraxel over the same area back and forth many times. The patient stated the symptoms began showing within a week of the treatment, and that they used burcamine gel to treat the burned area. Additional medical information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00111 |
| MDR Report Key | 9413301 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-12-04 |
| Date of Report | 2019-11-05 |
| Date of Event | 2018-04-18 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-12-04 |
| 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 | JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| 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 | 0 |
| Previous Use Code | 0 |
| 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 | 2019-12-04 |
| Model Number | SYS-SR1500-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | 11720 NORTH CREEK PKWY SUITE 100 BOTHELL WA 98011 US 98011 |
| Product Code | --- |
| Date Received | 2019-12-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-04 |