BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREST ORAL DISCLOSING TABLETS

    MDR report key: 1346811 · Received March 18, 2009

    Report

    Report Number
    MW5010380
    Event Type
    Malfunction
    Date Received
    March 18, 2009
    Date of Event
    February 18, 2009
    Report Date
    March 18, 2009
    Manufacturer
    YOUNG DENTAL MANUFACTURING
    Product Code
    LFC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER RECEIVED CREST ORAL DISCLOSING TABLETS FROM HER SCHOOL. NO UNIQUE IDENTIFYING LOGO ON TABLET FACE. NO CHILD RESISTANT PACKAGING. IS THIS PRODUCT REGULATED? COULD NOT FIND IT LISTED IN ORANGE BOOK. IS IT EVEN APPROVED? SOME TABLET INGREDIENTS ARE LISTED BY PROPRIETARY NAME -EMDEX, EXPLOTAB, CHERRY FLAVOR, D&C RED 28 DYE, MAGNESIUM STEARATE- . . . THOSE NAMES WOULD MEAN NOTHING TO A LAY PERSON. DYE ADHERES TO PLAQUE ON TEETH AS INDICATOR OF POOR TEETH BRUSHING. ACCOMPANYING LITERATURE STATES "CREST SUPER TABS" YET PRODUCT FOIL POUCH IS LABELED CREST NON DISCLOSING TABLETS. NOT SURE IF THESE ARE TECHNICALLY CONSIDERED A DRUG/DIAGNOSTIC DEVICE?? I DOUBT IT IS A VITAMIN/FOOD PRODUCT. NO ONE AT THE FDA CAN ANSWER MY QUESTION. FDA SUGGESTED THAT I FILL OUT A MEDWATCH REPORT. LITERATURE STATES TO USE UNDER SUPERVISION OF ADULT YET PRODUCT IS TARGETED TO CHILDREN -1ST GRADE- BY CREST AND IS PACKAGED IN NON-CR PACKAGING. DOSE OR AMOUNT: 1 TABLET. FREQUENCY: AFTER BRUSHING. ROUTE: DENTAL. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TO SHOW AREAS OF POOR BRUSHING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREST ORAL DISCLOSING TABLETS CREST SUPER TABS LFC YOUNG DENTAL MANUFACTURING CT600
    2 CREST SUPER TABS NONE LFC YOUNG DENTAL MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR