BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA TEMP

    MDR report key: 831069 · Received March 21, 2007

    Report

    Report Number
    MW1042337
    Event Type
    Injury
    Date Received
    March 21, 2007
    Date of Event
    February 5, 2007
    Report Date
    March 21, 2007
    Manufacturer
    EXACTA DENTAL PRODUCTS, INC.
    Product Code
    ELZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AFTER PERFORMING LENGTHY BUT ROUTINE DENTAL REPAIR, THE PT EXPERIENCED SWELLING OF MUCOSAL TISSUE ADJACENT TO MATERIAL, CAUSED SLOUGHING, AND EVENTUALLY SUBSIDED AFTER THE USE OF DIPROLENE. THE PRODUCT WAS EXACTA TEMP-ORARY-CROWN AND BRIDGE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA TEMP * ELZ EXACTA DENTAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR