MalfunctionEBC
CAULK TOOTH CONDITIONER GEL 34%
Received Sep 16, 2003 · Event occurred Aug 11, 2003
Report 2515379-2003-00124 · MDR key 484870
Device
Generic name
Pit & Fissure Sealant And Conditioner
Manufacturer
Dentsply CaulkModel number
NACatalog number
646125
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE DOCTOR REPORTED WHILE EXTRUDING TOOTH CONDITIONER GEL THE TIP CAME OFF AND THE MATERIAL WENT INTO THEIR EYE. THE DOCTOR IMMEDIATELY RINSED THE EYE WITH WATER AND THERE WAS NO REPORT OF INJURY.