MalfunctionEAY
COLTOLUX CURING LIGHT
Received Feb 14, 1997 · Event occurred Feb 4, 1997
Report 2416455-1997-00001 · MDR key 70416
Device
Generic name
Visible Light Curing Dental Material
Manufacturer
Coltene/whaldent Inc.Model number
C-7921Catalog number
C-7921
Lot number
*
Patient
NA
Narrative
Description of Event or Problem
RECEIVED A TELEPHONE CALL THAT REPORTED THAT THE LIGHT GUIDE OF A CURING LIGHT HAD "EXPLODED" IN THE PT'S MOUTH WHILE LIGHT CURING A RESTORATION. DUE TO THE FACT THAT THE DENTIST HAD PLACED RUBBER DAM, THERE WERE NO ADVERSE EFFECTS TO THE PT. THE LIGHT GUIDE IS ALL AN ACCESSORY DEVICE TO THE CURING LIGHT.