InjuryEBC
DELTON PIT & FISSURE SEALANT
Received Feb 10, 2005
Report 2515379-2005-00017 · MDR key 572127
Device
Generic name
Pit And Fissure Sealant And Conditioner
Manufacturer
Dentsply CaulkModel number
NACatalog number
27961
Lot number
0405041
Product problems
- Unknown (for use when the device problem is not known)
Patient
14 YR
- Allergic reaction
- Itching Sensation
- Swelling
Narrative
Description of Event or Problem
A PT EXPERIENCED SWELLING AND ITCHING OF THE TONGUE AND CHEEK AFTER USE OF DELTON, INDICATING A POSSIBLE ALLERGIC REACTION TO THE MATERIAL OF A CONSTITUENT PART. THE SYMPTOMS RESOLVED WITHOUT THE MEDICAL OR SURGICAL INTERVENTION.