BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASIL ULTRA

    MDR report key: 3092386 · Received April 30, 2013

    Report

    Report Number
    2515379-2013-00015
    Event Type
    Injury
    Date Received
    April 30, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    ELW
    PMA / PMN Number
    K021416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 EVAL 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 A PT EXPERIENCED A TINGLING SENSATION AND A RASH AFTER HAVING A DENTAL IMPRESSION TAKEN WITH AQUASIL. THE PT'S SYMPTOMS ABATED WITHOUT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188131 AQUASIL ULTRA ELW DENTSPLY CAULK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other