MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-21 for SYNERON EMAX MACHINE WITH SRA HEAD EMAX BY SYNERON manufactured by Syneron.
[15206859]
Pt came in for a fotofacial (skin rejuvenation, photofacial) which uses intense pulsed light (ipl) combined with radio frequency (rf). The setting was 25 j/cm2 on the optical fluence and 25 j/cm3 on the radio frequency energy. The pt's entire face was treated including the under eye area. The machine used was the emax by syneron with the sra head. Since the treatment, the pt has had denting in the skin, wrinkly skin, creepy texture, bumpy skin, skin atrophy, fat atrophy, and vision problems. The emax machine by syneron is unsafe. Please look at pulling this machine from the market before it harms others. The rf setting of 25 is the maximum the machine will allow. Treatment was performed at (b)(6), pa. Reason for use: spider veins on the cheeks of the face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023952 |
| MDR Report Key | 2430038 |
| Date Received | 2012-01-21 |
| Date of Report | 2012-01-21 |
| Date of Event | 2011-11-10 |
| Date Added to Maude | 2012-01-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERON EMAX MACHINE WITH SRA HEAD |
| Generic Name | FOTOFACIAL OR SKIN REJUVENATION |
| Product Code | OHS |
| Date Received | 2012-01-21 |
| Model Number | EMAX BY SYNERON |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON |
| Manufacturer Address | EMAX BY SYNERON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-21 |