BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPREGUM F

    MDR report key: 272176 · Received March 30, 2000

    Report

    Report Number
    9611385-2000-00003
    Event Type
    Other
    Date Received
    March 30, 2000
    Date of Event
    March 1, 2000
    Report Date
    March 14, 2000
    Manufacturer
    ESPE DENTAL AG
    Product Code
    ELW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE MIXING IMPREGUM F BASE PASTE AND CATALYST, ACRID GASSES CAUSED INJURIES IN THE EYES OF THE DENTAL ASSISTANT. AN OPHTHALMOLOGIST WAS SEEN WHO COULD DETECT CONJUNCTIVITIS. AFTER APPLICATION OF OINTMENT, THE ASSISTANT WAS ABLE TO RETURN TO THEIR WORK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPREGUM F POLYETHER IMPRESSION MATERIAL ELW ESPE DENTAL AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention