BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXITIME XTREME 2 HEAVY TRAY

    MDR report key: 5969607 · Received September 22, 2016

    Report

    Report Number
    3011203516-2016-00001
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    April 1, 2016
    Report Date
    September 19, 2016
    Manufacturer
    HERAEUS KULZER, SRL
    Product Code
    ELW
    PMA / PMN Number
    K101617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2015010, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER SRL(THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE ARE REPORTING TO MAINTAIN COMPLIANCE WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. AT THE CEMENT APPOINTMENT IN (B)(6) THE PATIENT STATED THAT HER TONGUE AND THROAT SWELLED JUST A LITTLE AFTER THE CROWN PREP. PATIENT SAID IT LASTED 3 DAYS. SHE TOOK BENADRYL FOR 5 DAYS. DR. REFERRED HER TO AN ALLERGIST FOR LIDOCAINE TESTING AT THE TIME. (B)(6). STATED THAT THE PATIENT NEVER FOLLOWED UP WITH THE ALLERGIST. (B)(6). DID CONFIRM THAT THE PATIENT HAS KNOWN ALLERGIES TO ARTIFICIAL SWEETENERS AND IS MORE SENSITIVE TO SACCHARINE AND ASPARTAME. DURING OUR CONVERSATION, (B)(6). ALSO STATED THAT BENCO'S VALUELINE MONOPHASE IMPRESSION MATERIAL WAS ALSO USED DURING THE PROCEDURE. HERAEUS KULZER, LLC CONTACTED HERAEUS KULZER (B)(4) IN REGARDS TO WHETHER THIS PRODUCT CONTAINED ARTIFICIAL SWEETENERS. (B)(4) CONFIRMED THAT THEY DO NOT. NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    PATIENT INFORMED DDS THAT HER TONGUE AND THROAT SWELLED JUST A LITTLE AFTER THE CROWN PREP APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622871 FLEXITIME XTREME 2 HEAVY TRAY IMPRESSION MATERIAL ELW HERAEUS KULZER, SRL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FLEXITIME XTREME 2 CORRECT FLOW| VALUELINE MONOPHASE IMPRESSION MATERIAL BY BENCO| FLEXITIME XTREME 2 CORRECT FLOW| VALUELINE MONOPHASE IMPRESSION MATERIAL BY BENCO