DELTON LC
Received Apr 3, 2000 · Event occurred Dec 6, 1999
Report 2424472-2000-00004 · MDR key 272157
Device
Generic name
Pit & Fissure Sealant
Manufacturer
Preventive Care DivisionModel number
NACatalog number
UNK
Lot number
990317
Product problems
- Reaction
Patient
7 YR
- Anaphylactic Shock
- Blister(s)
- Itching Sensation
- Rash
- Swelling
- Other (for use when an appropriate patient code cannot be identified)
- Pallor
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
THE PT HAD A FISSURE SEALING ON THE FOUR FIRST MOLARS AT 9 AM. TWO HRS LATER THE PT'S CHEEKS WERE SWOLLEN AND FULL OF BIG LIGHT BLISTERS. IN ADDITION, PT'S HANDS SHOWED SWELLING AND A REDDISH RASH. PT'S BODY ITCHED, AND PT WAS PALE AND FELT SICK. TWO DENTISTS DIAGNOSED AN ANAPHYLACTIC SHOCK. THE PT WAS GIVEN AN INJECTION OF 0.3 ML ADRENALINE 1MG/ML SUBGIGIVALLY AND 0.5 ML DECADRONE 4 MG/DL IN THE THIGH. AT THE SAME TIME, AN ANBULANCE WAS CALLED. AFTER TWO MINUTES PT'S CONDITION WAS CLEARLY BETTER. THE SWELLING AND THE RASH WERE QUICKLY DECREASING. THE AMBULANCE ARRIVED AND THE RESCUE TEAM CONFIRMED THE ABOVE DIAGNOSIS. THE PT WAS TAKEN TO THE EMERGENCY ROOM AND AT 1 PM WAS MUCH BETTER.