BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASIL ULTRA

    MDR report key: 3212739 · Received July 3, 2013

    Report

    Report Number
    2515379-2013-00031
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    ELW
    PMA / PMN Number
    K021416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE 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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. 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

    IN THIS EVENT IT WAS REPORTED THAT THE PATIENT EXPERIENCED PUFFY EYES, A SWOLLEN FACE AND AN ITCHY THROAT AFTER USE OF AQUASIL ULTRA, AS WELL AS OTHER NON-DENTSPLY PRODUCTS. THE PATIENT WAS GIVEN BENADRYL AND THE REACTION SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304550 AQUASIL ULTRA ELW DENTSPLY CAULK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ANESTHESIA| TEMP CEMENT| ASTRINGENT| CORD