BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVOCAP PREFERENCE

    MDR report key: 8175422 · Received December 18, 2018

    Report

    Report Number
    9612352-2018-00002
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 13, 2018
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EBI
    PMA / PMN Number
    K896130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, A DENTIST REPORTED THAT A PATIENT WAS HOSPITALIZED ON (B)(6) 2018 AFTER EXPERIENCING ANAPHYLACTIC SHOCK. THE DOCTOR CONFIRMED THE PATIENT HAD BEEN A DENTURE WEARER AND PRESENTED WITH EXISTING FULL UPPER AND LOWER DENTURES. THE INSERTION OF NEW DENTURES WAS ON (B)(6) 2019. THE PATIENT WAS SEEN AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2018, AT THIS APPOINTMENT AN ADJUSTMENT WAS MADE AND ORAL EXAMINATION SHOWED PINK, HEALTHY TISSUE. THE DENTIST WAS NOT AWARE OF ANY HISTORY OF ALLERGY TO ANY OF THE MATERIALS UTILIZED IN THIS CASE AND SUSPECTS THE REACTION THAT OCCURED ON (B)(6) IS UNRELATED TO THE DENTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013217 IVOCAP PREFERENCE RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI IVOCLAR VIVADENT AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization