MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-25 for FRAXEL RE:STORE LASER SYSTEM FRAXEL SYSTEM manufactured by Solta Medical.
[109300181]
It is not possible to confirm the details of the treatment or perform an evaluation of the device as the patient has declined to provide any further information.
Patient Sequence No: 1, Text Type: N, H10
[109300182]
A patient called to report she has had 4-6 fraxel treatments for acne scars and she now has melasma at the treatment site. The patient declined to provide any additional information regarding the treatment or the treating facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00051 |
| MDR Report Key | 7545353 |
| Report Source | CONSUMER |
| Date Received | 2018-05-25 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-04-30 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-25 |
| 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 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 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 | 2018-05-25 |
| Model Number | FRAXEL SYSTEM |
| ID Number | NI |
| 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 |
| Manufacturer Address | 11720 N CREEK PARKWAY N STE100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-25 |