TOOTH CONDITIONER GEL SYRINGE
Received Oct 22, 2002
Report 2515379-2002-00048 · MDR key 424586
Device
Generic name
Dental Tooth Conditioner
Manufacturer
Dentsply CaulkModel number
NACatalog number
646125
Lot number
020405
Product problems
- Partial Blockage
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CLOGGED.
Description of Event or Problem
THE RETURNED SYRINGE WAS DIFFICULT TO EXTRUDE, BUT PROPERLY STORED RETAINED SYRINGES EXTRUDED NORMALLY. CO'S CONCLUSION IS THTA THE DOCTOR DID NOT PROPERLY STORE THE FILLED SYRINGE.
Description of Event or Problem
THE RETURNED SYRINGE WAS DIFFICULT TO EXTRUDE. THE TIP IOS COMPONENT #746129, AND THE FILLED SYRINGE IS COMPONENT #946125. WHEN APPLYING THE PRODUCT, THE DOCTOR ATTACHES AN UNUSED TIP TO THE FILLED SYRINGE AND EXTRUDES THE MATERIAL THROUGH THE TIP.
Description of Event or Problem
TIPS WERE ATTACHED TO THE SYRINGES AND THE SYRINGES WERE THEN EXTRUDED. THERE IS NO FORMALLY DOCUMENTED METHOD FOR THIS EXTRUSION TEST; IT IS GENERALLY ASSOCIATED WITH APPEARANCE METHOD GM-062-89.