BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASIL ULTRA

    MDR report key: 1233939 · Received November 14, 2008

    Report

    Report Number
    2515379-2008-00115
    Event Type
    Injury
    Date Received
    November 14, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DENTSPLY CAULK
    Product Code
    ELW
    PMA / PMN Number
    K021416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE AQUASIL USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT IS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH KNOWN ALLERGIES TO MINT DEVELOPED SORENESS OF THE GINGIVA AFTER AN IMPRESSION WAS TAKEN USING AQUASIL ULTRA. THE FOLLOWING DAY, THE PATIENT REPORTED TENDERNESS, SOME BLEEDING, AND A RASH-LIKE REACTION OF THE ORAL MUCOSA. AN ORAL RINSE APPARENTLY PREVIOUSLY PRESCRIBED OR RECOMMENDED BY THE PATIENT'S PHYSICIAN WAS USED TO TREAT THE SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other