InjuryEBC
DELTON PIT & FISSURE SEALANT
Received Aug 17, 2004 · Event occurred Jul 1, 2004
Report 2515379-2004-00389 · MDR key 539561
Device
Generic name
Pit And Fissure Sealant And Conditioner
Manufacturer
Dentsply ProfessionalModel number
NACatalog number
27961
Lot number
UNK
Product problems
- Device, removal of (non-implant)
Patient
12 YR
- Allergic reaction
- Hives
Narrative
Description of Event or Problem
A PT BROKE OUT IN HIVES AFTER HAVING FOUR DELTON SEALANTS PLACED INDICATING A POSSIBLE ALLERGIC REACTION. IT WAS REPORTED THAT THE PT WENT TO THE HOSP 3 TIMES, BUT NO INDICATION OF WHAT IF ANY TREATMENT WAS RENDERED. REMOVAL OF THE SEALANTS, HOWEVER, RELIEVED THE SYMPTOMS.