BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAK ELASTIC ACRYLIC RESIN

    MDR report key: 229597 · Received June 24, 1999

    Report

    Report Number
    MW1016619
    Event Type
    Other
    Date Received
    June 24, 1999
    Date of Event
    May 26, 1999
    Report Date
    June 22, 1999
    Manufacturer
    CMP INDUSTRIES, INC.
    Product Code
    EBG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    APPLIANCE FABRICATED IN LABORATORY AND INSERTED IN MOUTH ON ABOVE DATE. WITHIN ONE DAY, PT DEVELOPED CONSTANT NAUSEA AND COULD NOT EAT. PT REMOVED APPLIANCE AFTER 2 1/2 DAYS, AND NAUSEA DISAPPEARED AFTER 48 HRS HAD ELAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAK ELASTIC ACRYLIC RESIN INTRA-ORAL ORTHOTIC DEVICE - REMOVABLE EBG CMP INDUSTRIES, INC. STOCK # 3306 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ETHYL - METHACRYLATE MONOMER 80-100%.