BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MI VARNISH

    MDR report key: 3113569 · Received May 2, 2013

    Report

    Report Number
    1410097-2013-00001
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 10, 2013
    Manufacturer
    GC CORP.
    Product Code
    LBH
    PMA / PMN Number
    K102808
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SVC INTERVIEWED HEALTHCARE PROFESSIONAL. PT HAD AUTHORIZED USE OF MEDICAL DEVICE.

    Description of Event or Problem · 1

    DR. REPORTED ALLERGIC REACTION TO PRODUCT. DURING MEDICAL HISTORY IT WAS NOTED THAT PT HAD FOOD ALLERGIES TO NUTS AND SEAFOOD. OTHER ALLERGIES REVIEWED RELATED TO THE PRODUCT ARE MILK ALLERGY, PINE TREE EXTRACT ROSIN AND PRESERVATIVES. PT'S MOTHER GAVE PERMISSION TO THE HEALTHCARE PROFESSIONAL TO USE THE PRODUCT. PT WAS THEN GIVEN A VARNISH TREATMENT AND SOON STARTED TO COMPLAIN THAT HER THROAT WAS CLOSING UP. PT'S MOTHER HAD AN EPI PEN AND IMMEDIATELY DISPENSED IT TO THE PT. ADVERSE REACTION SUBSIDED. CONTINUED CONTACT WITH DENTAL OFFICE YIELDED NO FURTHER MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193289 MI VARNISH FLUORIDE VARNISH LBH GC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention