CAULK TOOTH CONDITIONER GEL 34%
Received Aug 17, 2006 · Event occurred Jul 18, 2006
Report 2515379-2006-00369 · MDR key 751733
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Eye Burn
Narrative
Description of Event or Problem
AN OPHTHALMOLOGIST REPORTED THAT A PATIENT SUSTAINED A CORNEAL BURN AFTER EXPOSURE TO TOOTH CONDITIONER GEL; THE REPORTER DISCONNECTED THE CALL BEFORE PROVIDING ANY FURTHER INFORMATION.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN WHAT, IF ANY, INTERVENTION WAS REQUIRED TO TREAT THE BURN, IT IS LIKELY THAT SUCH AN INJURY WOULD REQUIRE INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE AND PERMANENT IMPAIRMENT OF A BODY FUNCTION. THERE IS NOT ENOUGH INFORMATION AVAILABLE AT THIS TIME TO DETERMINE WHETHER THE PRODUCT MALFUNCTIONED OR NOT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.