BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL POWDER

    MDR report key: 32255 · Received April 25, 1996

    Report

    Report Number
    MW1008961
    Event Type
    Injury
    Date Received
    April 25, 1996
    Manufacturer
    UNKNOWN
    Product Code
    EJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT DOES NOT LIST IT'S CONTENTS WHICH ARE SWALLOWED WITH FOOD AT MEALS. THEY HOLD DENTAL PLATED WHEN FIRST APPLIED. VERY LITTLE REMAINS AT END OF THE DAY. RPTR ASKS CAN THE "GLUE" CONTENTS BE A HEALTH HAZARD AND ISN'T IT ILLEGAL NOT TO LIST CONTENTS. (ALSO SEE 1008960).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL POWDER POLISHING AGENT EJR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention