BITE PROOF BITE BLOCK; UNIVERSAL BITE BLOCK

Description of Event or Problem

"PATIENT WAS FOUND TO HAVE A PIECE OF TOOTH IN HER MOUTH. UNIVERSAL BITEBLOCK WAS USED FOR INTUBATION. PIECE OF TOOTH CAME FROM AND POINTS TO LEFT UPPER INCISOR WHICH IS PART OF A PERMANENT BRIDGE." DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).