BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIVA STAR SILVER DIAMINE FLUORIDE

    MDR report key: 8339473 · Received February 13, 2019

    Report

    Report Number
    MW5084053
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 5, 2019
    Manufacturer
    SDI LIMITED
    Product Code
    LBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS RIVA STAR SILVER DIAMINE FLUORIDE. IMMEDIATELY UPON PLACEMENT ON TOOTH TO ARREST DECAY ON A PRIMARY MOLAR, INFLAMMATION AND A CHEMICAL BURN OCCURRED. SHORTLY AFTER PLACEMENT THERE WAS REDNESS AT THE GUMLINE AND ON THE VERMILLION BORDER OF THE LIP. SHORTLY HEREAFTER THERE WAS SOME TISSUE SLOUGH AT THE GUMLINE AND A BROWN TO BLACK SPOT OCCURRED ON THE LIP. WHILE GAUZE AND COTTON ROLLS HAD BEEN USED FOR ISOLATION IT WAS NOT ADEQUATE. NOTE: DEVICE 510(K) : K172047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127491 RIVA STAR SILVER DIAMINE FLUORIDE CAVITY VARNISH LBH SDI LIMITED 11272371

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other