BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN ETCH GEL 40%

    MDR report key: 1327332 · Received February 25, 2009

    Report

    Report Number
    MW5010099
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 25, 2009
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Product Code
    KLE
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL PATIENT -FEMALE RECEIVED DENTAL RESTORATION TREATMENT INVOLVING TOOTH ETCHANT GEL. TOWARD THE END OF THE APPOINTMENT, A BLUE-ISH MARK WAS REMOVED WITH A WET 2X2 -DENTIST ASSUMED THIS WAS DYE FROM THE ARTICULATING PAPER-. THE PATIENT CALLED THE NEXT MORNING REPORTING WHAT APPEARED TO BE 2 BURNS ON HER CHEEK WITH NO PAIN OR TENDERNESS. THE PATIENT WAS EXAMINED BY A DERMATOLOGIST IN 2009 WHO CONFIRMED TWO INFLAMED LESIONS ON THE LEFT CHEEK THAT COULD BE CONSISTENT WITH CHEMICAL IRRITATION OR MILD CHEMICAL BURN AND PRESCRIBED BIAFINE CREAM. THE ETCHANT INSTRUCTIONS FOR USE STATE "CONTAINS PHOSPHORIC ACID THAT CAN BE HARMFUL TO SKIN, MUCOSA AND EYES. IN CASE OF CONTACT WITH ANY OF THESE TISSUES, FLUSH IMMEDIATELY WITH COPIOUS AMOUNTS OF WATER AND SEEK MEDICAL ASSISTANCE FOR APPROPRIATE TREATMENT." DOSE OR AMOUNT: THIN LAYER TO TOOTH ENAMEL. FREQUENCY: ONCE. ROUTE: TOP. DATES OF USE: 2009 - ONCE. DIAGNOSIS OR REASON FOR USE: NORMAL DENTAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN ETCH GEL 40% DENTAL ETCHANT GET KLE CONFI-DENTAL PRODUCTS CO. I8510-3

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability