BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASIL ULTRA

    MDR report key: 582328 · Received March 17, 2005

    Report

    Report Number
    2515379-2005-00070
    Event Type
    Injury
    Date Received
    March 17, 2005
    Report Date
    February 15, 2005
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PT EXPERIENCED NUMBING AND TINGLING SENSATIONS AND LATER SWELLING AND SCALLOPING OF THE TONGUE WITH LESIONS AFTER MULTIPLE IMPRESSIONS WITH AQUASIL ULTRA MONOPHASE AND AQUASIL EASY MIX PUTTY, INDICATING A POSSIBLE ALLERGIC REACTION TO EITHER MATERIAL OR A CONSTITUENT PART. THE SYMPTOMS RESOLVED WITHOUT MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASIL ULTRA IMPRESSION MATERIAL EBH DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN