TITAN XL

Description of Event or Problem

SEPTEMBER 22, 2010: CUTERA WAS NOTIFIED BY TELEPHONE BY THE TREATMENT PROVIDER WITH REPORT OF A "BLISTER IN MIDDLE OF FOREHEAD THAT LEFT A DEEP SCAR." THE DATE OF TREATMENT WAS UNKNOWN. THE TREATMENT PROVIDER STATED THE TREATMENT WAS IN THE "SPRING OF 2009." THE TREATMENT PROVIDER WAS UNABLE TO PROVIDE THE FOLLOWING INFORMATION: TREATMENT DATE, PATIENT INFORMATION, TREATMENT INFORMATION OR ADVERSE EVENT INFORMATION. IT IS UNKNOWN IF THE PATIENT AND ADVERSE EVENT WAS EVALUATED.

Additional Manufacturer Narrative

FEBRUARY 29, 2008, TITAN XL HANDPIECE (B)(4) SOLD. OCTOBER 3, 2008: (B)(6) FSE REPAIR, REPAIR COMPLETE CASE #(B)(4) PREVENTIVE MAINTENANCE (HANDPIECE OPERATING WITHIN SPECIFICATION). FEBRUARY 26, 2009: (B)(6) FSE REPAIR, REPAIR COMPLETE USD CASE #(B)(4) COURTESY VISIT (HANDPIECE OPERATING WITHIN SPECIFICATION). SPRING 2009 - TREATMENT DATE. (B)(6) 2009: OUT OF SHOTS, SENT FOR REFILL/END OF LIFE EXPECTANCY. CLOSED RMA (B)(4) - ADMINISTRATIVE NON-COMPLAINT (B)(4) TITAN REFILL. THERE WERE NO OTHER REPORT OF ADVERSE EVENTS REPORTED FROM THIS ACCOUNT. THE HANDPIECE WAS EVALUATED TWICE FOR PREVENTIVE MAINTENANCE AND FOUND TO BE OPERATING WITHIN SPECIFICATION. THE HANDPIECE WAS USED TO ITS FULL LIFE EXPECTANCY WITH NO OTHER REPORT OF ADVERSE EVENT.