BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTON LC

    MDR report key: 272157 · Received April 3, 2000

    Report

    Report Number
    2424472-2000-00004
    Event Type
    Injury
    Date Received
    April 3, 2000
    Date of Event
    December 6, 1999
    Report Date
    March 31, 2000
    Manufacturer
    PREVENTIVE CARE DIVISION
    Product Code
    EBC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTON LC PIT & FISSURE SEALANT EBC PREVENTIVE CARE DIVISION NA 990317

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention