BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRADENT ULTRASEAL

    MDR report key: 2195361 · Received August 2, 2011

    Report

    Report Number
    MW5021619
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    June 9, 2000
    Report Date
    August 2, 2011
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    EBC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED DENTAL SEALANTS FOR BOTH MY CHILDREN WITH THE EXPECTATION THAT THEY WOULD PREVENT DECAY. FOR MY CHILDREN, THE OPPOSITE RESULT OCCURRED. RECENT X-RAYS REVEALED MULTIPLE CAVITIES UNDER THREE OF MY DAUGHTER'S SEALANTS, AND SINGULAR CAVITIES UNDER FOUR OF MY SONS. MY DAUGHTER IS (B)(6) AND MY SON IS (B)(6). NEITHER HAVE CAVITIES ELSEWHERE. MY CHILDREN HAVE RECEIVED CONSISTENT DENTAL CARE. MY DAUGHTER'S SEALANTS WERE APPLIED IN 2000 AND 2004. FREQUENCY: 8. DATES OF USE: (B)(6) 2000 - (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRADENT ULTRASEAL DENTAL SEALANT EBC ULTRADENT PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention