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 2018-08-24 for FRAXEL RE:STORE LASER SYSTEM SYS-SR1500-US manufactured by Solta Medical.
[118166930]
Investigation of this event is in progress.
Patient Sequence No: 1, Text Type: N, H10
[118166931]
A user facility called to report that a patient acquired redness and blistering to the nose, chin, and lower eyelid on the right side of the face, following a fraxel re:store treatment. Hydrocolloid dressings and cortisone were prescribed. On (b)(6) 2018 it was reported that the nature of the injury is a thermal burn that may result in some scarring. The patient is healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00079 |
| MDR Report Key | 7814305 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-07-05 |
| Date Added to Maude | 2018-08-24 |
| 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 SUITE 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 | 2018-08-24 |
| Model Number | SYS-SR1500-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 |
| Manufacturer Address | 11720 N CREEK PARKWAY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-24 |