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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNERONSYNERON EMAX MACHINE WITH SRA HEADFOTOFACIAL OR SKIN REJUVENATION

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SYNERON SYNERON EMAX MACHINE WITH SRA HEAD FOTOFACIAL OR SKIN REJUVENATION   Back to Search Results
Model Number EMAX BY SYNERON
Event Date 11/10/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

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.

 
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Brand NameSYNERON EMAX MACHINE WITH SRA HEAD
Type of DeviceFOTOFACIAL OR SKIN REJUVENATION
Manufacturer (Section F)
SYNERON
emax by syneron
Manufacturer (Section D)
SYNERON
emax by syneron
Device Event Key2454257
MDR Report Key2430038
Event Key2326879
Report NumberMW5023952
Device Sequence Number1
Product CodeOHS
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberEMAX BY SYNERON
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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