MalfunctionEBC
TOOTH CONDITIONER GEL
Received Oct 22, 2001 · Event occurred Sep 5, 2001
Report 2515379-2001-00018 · MDR key 358232
Device
Generic name
Dental Restorative Material
Manufacturer
L.d. CaulkModel number
NACatalog number
646125
Lot number
UNK
Product problems
- Failure To Adhere Or Bond
- Detachment Of Device Component
Patient
UNKNOWN
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A DENTIST WAS HAVING TROUBLE EXTRUDING TOOTH CONDITIONER GEL FROM THE SYRINGE. DENTIST PRESSED SO HARD ON THE SYRINGE THAT THE TIP CAME OFF OF THE SYRINGE AND MATERIAL WENT INTO THE PATIENT'S MOUTH. THE MATERIAL WAS SUCTIONED OUT IMMEDIATELY. THE PT DID NOT EXPERIENCE ANY DISCOMFORT AND THERE WAS NO INJURY.