MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for FRAXEL RESTORE 1550 manufactured by Solta Medical, Inc..
[143413543]
Reporter stated that she had facial laser treatment about 5 months ago and still suffers from the adverse effects. Pt said she lost all moisture barrier from her face and her skin does not hold lotion. She also has scarring on her face, enlarged pores, and has extremely dry skin. She also stated she can no longer be in the sun.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086209 |
| MDR Report Key | 8555741 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2018-11-21 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FRAXEL RESTORE 1550 |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM / FRACTIONAL OUTPUT |
| Product Code | ONG |
| Date Received | 2019-04-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |