BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENO III

    MDR report key: 1063156 · Received June 20, 2008

    Report

    Report Number
    8010638-2008-00052
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 21, 2008
    Manufacturer
    DENTSPLY DETREY
    Product Code
    KLE
    PMA / PMN Number
    K023776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE XENO III 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 REPORTABLE. 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 APPROXIMATELY THREE HOURS AFTER PLACEMENT OF A RESTORATION OR RESTORATIONS USING EXCITE, TETRIC, COMPOGLASS (NONE OF WHICH ARE MANUFACTURED BY DENTSPLY) IN CONJUNCTION WITH XENO III, THE PATIENT DEVELOPED A CHILL AND ERYTHRODERMIA ON THE FACE AND UPPER CHEST. THE SYMPTOMS LASTED A FEW MONTHS AND RESOLVED WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENO III KLE DENTSPLY DETREY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other EXCITE| COMPOGLASS| TETRIC