MalfunctionEBC
TOOTH CONDITIONER GEL
Received Aug 21, 2001 · Event occurred Aug 8, 2001
Report 2515379-2001-00011 · MDR key 348560
Device
Generic name
Dental Restorative Material
Manufacturer
L.d. CaulkModel number
NACatalog number
646125
Lot number
UNK
Product problems
- Detachment Of Device Component
- Difficult to Remove
- Physical Resistance
Patient
*
- Contamination, chemical
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A DENTIST WAS HAVING TROUBLE EXTRUDING TOOTH CONDITIONER GEL FROM THE SYRINGE AFTER THE FIRST OR SECOND USE. HE PRESSED SO HARD ON THE SYRINGE THAT THE TIP OF THE SYRINGE CAME OFF AND MATERIAL WENT ON THE PT'S SHIRT, FACE, AND UP THE PT'S NOSE. THE PT WAS TREATED IMMEDIATELY WITH A NASAL WASH. THERE WAS NO INJURY.