BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL ADHESIVE

    MDR report key: 434928 · Received December 22, 2002

    Report

    Report Number
    MW1027070
    Event Type
    Malfunction
    Date Received
    December 22, 2002
    Report Date
    December 22, 2002
    Manufacturer
    *
    Product Code
    KOM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT HAS DAWNED ON RPTR, AFTER CHANGING DENTAL ADHESIVES FROM FIXODENT TO CVS BRAND, THAT THERE IS NO INDICATION OF THE INGREDIENTS USED IN THE MANUFACTURE OF ANY BRAND OF ADHESIVE. RPTR. BELIEVES THAT SINCE THE PRODUCT IS INGESTED WHEN IT IS WASHED AWAY BY ONE'S OWN SALIVA AND SWALLOWED, THE END USER SHOULD KNOW WHETHER THEY ARE USING SOMETHING THAT MIGHT CONTAIN A SWEETENER OR ANY OTHER ITEM THEY SHOULD AVOID. MOST USERS ARE OF SENIOR STATUS AND CAN HAVE, FOR INSTANCE, DIABETES. THERE COULD BE A DISASTEROUS AFFECT IF THE ADHESIVE WOULD CONTAIN A SUGAR SUBSTANCE. RPTR IS ESPECIALLY CONCERNED BECAUSE THE CVS BRAND HAS SUCH A SWEET TASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL ADHESIVE * KOM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other