BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE ORTHODONTIC PRODUCTS LIQUID ETCHANT

    MDR report key: 2621165 · Received June 11, 2012

    Report

    Report Number
    1420089-2012-00001
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 4, 2012
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Product Code
    DYH
    PMA / PMN Number
    K113401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ORTHODONTIC OFFICE CALLED ON (B)(6) 2012, STATING THAT THE 9 GRAM LIQUID ETCHANT USED FOR THE PREPARATION OF TOOTH ENAMEL IN A BONDING PROCEDURE WAS CLOGGED. WHEN EXCESSIVE FORCE WAS USED TO DISPENSE THE PRODUCT, THE TIP EXPELLED AND THE CONTENTS OF THE PRODUCT (CONTAINING PHOSPHORIC ACID) FORCEFULLY SPLASHED ON THE SKIN OF THE USER. ON (B)(6) 2012, THE SAME ACCOUNT CONTACTED RELIANCE ORTHODONTICS VIA THE WEBSITE STATING THAT THE USER (A CHAIRSIDE ASSISTANT) HAD GOTTEN THE PRODUCT IN THEIR EYE AND REQUIRED AN OPTOMETRIST FOR FURTHER EVAL. THE USER WAS ADMINISTERED AN EYE SALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE ORTHODONTIC PRODUCTS LIQUID ETCHANT PHOSPHORIC ACID ETCHANT DYH RELIANCE ORTHODONTIC PRODUCTS, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other