BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANAVIA 2.0 RESIN CEMENT

    MDR report key: 1953617 · Received January 5, 2011

    Report

    Report Number
    MW5018889
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    July 20, 2005
    Report Date
    December 28, 2010
    Manufacturer
    KURARAY AMERICA, INC., DENTAL DEPT.
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED GLOSSITIS AND BURNING MOUTH AFTER RECEIVING PORCELAIN VENEERS. PT REPORTED BEING ALLERGIC TO ACRYLIC. IT WAS SUSPECTED THAT THE PANAVIA 2.0 CEMENT MADE BY KURARAY WAS THE CAUSE OF THE REACTION SINCE IT CONTAINS ACRYLIC. GLOSSITIS AND BURNING MOUTH IMPROVED WHEN THE VENEERS AND PANAVIA CEMENT WERE TAKEN OUT AND REPLACED WITH PORCELAIN CROWNS AND A NON-ACRYLIC CEMENT. PT REPORTED ACRYLIC ALLERGY BEFORE THE DENTIST PLACED THE VENEERS. KURARAY PUTS A WARNING ON THE PANAVIA NOT TO USE IT IN PEOPLE WITH ACRYLIC ALLERGIES. THAT MAKES THIS A PRODUCT USE ERROR BY THE DENTIST AS WELL AS AN ADVERSE EVENT. DATES OF USE: (B)(6) 2004 TO (B)(6) 2006. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANAVIA 2.0 RESIN CEMENT NONE EBF KURARAY AMERICA, INC., DENTAL DEPT. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention