BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN ETCH GEL 40%

    MDR report key: 1336973 · Received March 3, 2009

    Report

    Report Number
    1721729-2009-00001
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 11, 2009
    Manufacturer
    NOVOCOL, INC.
    Product Code
    KLE
    PMA / PMN Number
    K030743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATERIAL IS A BLUE ETCHANT GEL USED IN THE DENTAL INDUSTRY TO ETCH ENAMEL AND DENTIN ON TEETH. IT IS A 40% PHOSPHORIC ACID SOLUTION AND, IF ACCIDENTALLY ALLOWED TO CONTACT SKIN AND NOT IMMEDIATELY RINSED OFF WITH A SUFFICIENT AMOUNT OF WATER, WILL PRODUCE A CHEMICAL BURN. THE DENTIST MAY HAVE MISTAKEN THE BLUE COLOR FROM THE ETCH GEL FOR A DYE STAIN FROM ARTICULATING PAPER, WHICH IS USED DURING THE SAME PROCEDURE (AS STATED BY THE DENTIST). THE ETCHANT INSTRUCTIONS FOR USE STATES "CONTAINS PHOSPHORIC ACID THAT CAN BE HARMFUL TO SKIN, MUCOSA AND EYES. IN CASE OF CONTACT WITH ANY OF THESE TISSUES, FLUSH WITH COPIOUS AMOUNTS OF WATER AND SEEK MEDICAL ASSISTANCE FOR APPROPRIATE TREATMENT." SINCE THE SPECIFIC DEVICE ASSOCIATED WITH THE ADVERSE EVENT WAS NOT RETURNED TO CONFI-DENTAL, AN EVALUATION WAS PERFORMED ON A RETAINED SAMPLE OF THE SAME LOT OF MATERIAL. THE AMOUNT OF PHOSPHORIC ACID WAS FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2009, A DENTAL PT (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 GAUZE (DENTIST ASSUMED THIS WAS DYE FROM THE ARTICULATING PAPER). THE PT CALLED THE NEXT MORNING, REPORTING WHAT APPEARED TO BE TWO BURNS ON HER CHEEK WITH NO PAIN OR TENDERNESS. THE PT WAS EXAMINED BY A DERMATOLOGIST, THREE DAYS LATER, WHO CONFIRMED TWO INFLAMED LESIONS ON THE LEFT CHEEK THAT COULD BE CONSISTENT WITH CHEMICAL IRRITATION OR MILD CHEMICAL BURN, AND PRESCRIBED BIAFINE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN ETCH GEL 40% DENTAL ETCHANT GEL KLE NOVOCOL, INC. I8510-3

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention