OtherILY
CUTERA TITAN
Received Nov 30, 2006 · Event occurred Oct 14, 2006
Report 2954354-2006-00001 · MDR key 791322
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Therapy/non-surgical treatment, additional
- Burn, Thermal
Narrative
Description of Event or Problem
PT WAS TREATED WITH TITAN AND REC'D SUPERFICIAL BURNS ON THE SUBMENTAL AREA. PT WAS TREATED ON FULL FACE AND NECK WITH NO PROBLEM. ADVERSE EVENT WAS REPORTED ONLY IN ONE AREA. EARLY PHOTOGRAPHS SHOWED PT WAS HEALING, BUT DUE TO NO FOLLOW UP PHOTOS OR INFO, IT IS UNKNOWN IF PT WILL HAVE ANY PERMANENT EFFECT.
Additional Manufacturer Narrative
DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED. THERE WAS NO DEVICE MALFUNCTION THAT WOULD CAUSE THIS INJURY. PHYSICIAN HAD CONTINUED TO TREAT PATIENTS AFTER THE INJURY WITH NO ADDITIONAL ADVERSE EVENTS.