BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTEGRITY TEMPORARY MATERIAL

    MDR report key: 407576 · Received July 26, 2002

    Report

    Report Number
    2515379-2002-00033
    Event Type
    Other
    Date Received
    July 26, 2002
    Report Date
    July 26, 2002
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A VESICLE ON THE ORAL MUCOSA. SYMPTOMS DISAPPEARED WITH REMOVAL OF THE TEMPORARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY TEMPORARY MATERIAL DENTAL PROVISIONAL MATERIAL EBG DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ZONE (TEMPORARY CEMENT).