BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP CARE

    MDR report key: 2493828 · Received March 12, 2012

    Report

    Report Number
    MW5024650
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    TOPCO ASSOCIATES
    Product Code
    KOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT PURCHASED: TOPCARE DENTAL ADHESIVE 2.4 OZ. TUBE (TOPCO ASSOCIATES, LLC (B)(4)). PRODUCT ERROR: STATES "COMPARE TO FIXODENT ORIGINAL". NO PRODUCT INGREDIENTS ARE LISTED ON BOX, OR TUBE. NO LOT NUMBER OR CODES ARE PRINTED ON BOX OR TUBE. CANNOT TELL WHAT IS IN IT. THIS IS AN ORAL "MEDICATION" DIRECTLY APPLIED TO ORAL TISSUES, AND PRODUCTS CAN BE READILY ABSORBED...NO ALLERGY INFORMATION? NO "ANYTHING" LISTED WITH THIS PRODUCT, INSIDE OR OUT. IN LIGHT OF RECENT ZINC ISSUES, WHY WAS DENTAL ADHESIVES DELISTED AS DEVICE, AND ESSENTIALLY UNREGULATED? (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOP CARE DENTURE ADHESIVE CREAM KOL TOPCO ASSOCIATES NONE NONE

    Patients

    Seq Age Sex Outcome Treatment
    1