inforMED
InjuryEBC

DELTON PIT & FISSURE SEALANT

Received Apr 7, 2006 · Event occurred Mar 10, 2006

Report 2515379-2006-00154 · MDR key 697983

Device

Generic name

Ebc

Model number

NA

Catalog number

27961

Lot number

050217

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Allergic reaction

Narrative

Description of Event or Problem

A PT EXPERIENCED AN ALLERGIC REACTION ON THE FACE AND BODY AFTER A PROCEDURE WAS PERFORMED USING DELTON LC. THE SYMPTOMS RESOLVED WITHIN A FEW HRS, APPARENTLY WITHOUT ANY INTERVENTION.