BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIOMOLAR HB

    MDR report key: 465428 · Received June 6, 2003

    Report

    Report Number
    MW1028656
    Event Type
    Other
    Date Received
    June 6, 2003
    Date of Event
    June 4, 2003
    Report Date
    June 6, 2003
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Product Code
    EBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IVOCLAR VIVADENT, INC. MAKES A PRODUCT THAT IS MARKETED UNDER THE NAME HELIOMOLAR HB SHADES TRANSLUCENT GRAY AND TRANSLUCENT WHITE THAT THEY INDICATE IS RADIOPAQUE IN ALL THEIR WRITTEN MATERIAL. IT IS NOT RADIOPAQUE. IT IS RADIOLUCENT SO THAT IT DOES NOT SHOW UP ON DENTAL X-RAYS. THEREFORE THE PRACTITIONER DOES NOT KNOW IF THE TOOTH HAS A PROPER FILLING PLACED OR DECAY IS PRESENT IN THE TOOTH OR A DEFECTIVE FILLING. ALL SUCH FILLINGS WILL HAVE TO BE REPLACED AT CONSIDERABLE COST, PAIN AND FINANCIAL LOSS TO PTS OR THE DENTIST. AS OF YESTERDAY THE CO SERVICE STILL HAD THEIR PEOPLE INDICATING THAT THE PRODUCT WAS RADIOPAQUE. UPON PRESSING THE ISSUE WITH THEIR "SCIENCE DEPARTMENT" THEY ADMITTED IT WAS RADIOLUCENT RATHER THAN RADIOPAQUE AS EXPLAINED IN THEIR WRITTEN AND VERBAL SUPPORT TO THE DENTAL PROFESSION. ROTR FEELS THIS IS A CATASTROPHIC FRAUD. AS THE STANDARD FOR YEARS IS THAT FILLING MATERIAL FOR INTERPROXIMAL RESTORATIONS BE ABSOLUTELY RADIOPAQUE. RPTR FEELS THEIR NEEDS TO BE IMMEDIATE ACTION BY THE CO TO CORRECT THIS MISINFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOMOLAR HB POSTERIOR DENTAL COMPSITE FILLING MATERIAL EBF IVOCLAR VIVADENT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other