BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRUDE MPV

    MDR report key: 480989 · Received August 28, 2003

    Report

    Report Number
    1815757-2003-00001
    Event Type
    Injury
    Date Received
    August 28, 2003
    Date of Event
    July 9, 2003
    Report Date
    August 27, 2003
    Manufacturer
    KERR CORP.
    Product Code
    ELW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2003, AN IMPRESSION OF A PATIENT'S DENTITION WAS TAKEN AT A GENERAL DENTIST'S OFFICE. THE DENTIST ALLEGED THE IMPRESSION MATERIAL DID NOT SET IN A TIMELY MANNER WHICH LEFT RESIDUAL MATERIAL IN THE PATIENT'S GINGIVAL. THE PATIENT LATER COMPLAINED OF LUMPS IN THE GUMS AND WAS REFERRED TO AN ORAL SURGEON FOR REMOVAL OF THE MATERIAL. THE ORAL SURGEON SURGICALLY REMOVED 1/2 CM OF IMPRESSION MATERIAL FROM THE PATIENT'S GUM WHICH REACHED INTO THE CHEEK REGION. THE ORAL SURGEON EXPRESSED CONCERN THAT HE DID NOT UNDERSTAND HOW IMPRESSION MATERIAL ENTERED INTO THE GINGIVAL AND INTO THE CHEEK REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRUDE MPV IMPRESSION MATERIAL ELW KERR CORP. UNK 2-1200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention