BEUDAMED
    FDA Adverse Event Other Summary report: N

    XANTOPREN

    MDR report key: 2142522 · Received June 2, 2011

    Report

    Report Number
    1925223-2011-00013
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    March 5, 2008
    Report Date
    May 31, 2011
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    ELW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ALLERGIC REACTION AFTER IMPRESSION FOR RELINING PROSTHESES. IMPRESSION TAKEN WITH XANTOPREN L BLUE/XANTOPREN H GREEN, AND ACTIVATOR UNIVERSAL PLUS PASTE. ACCORDING TO DENTIST UNSUSPICIOUS IMPRESSION TAKING. NO REACTION OF THE PT. ACCORDING TO THE PT INTENSIVE BURNING, THAT SHE HAS DIRECTLY REPORTED TO THE DENTIST. RELINING WITH PROBASE COLD, COMP. INVOCLAR (MMA, DBPO SYSTEM), PRODUCED IN THE DENTAL LAB BELONGING TO THE DENTAL PRACTICE. THIS PRODUCT WAS NOT CONSIDERED TO BE THE CAUSE OF THE NEGATIVE SENSATION BEFORE THE DATE OF THE PHONE CALL. BUILD-UP OF GLAUCOMA, SEVERE SWELLING OF THE PT'S EYE, SELF TREATMENT OF THE PT WITH POLYSPECTRAN (BASED ON THE PT'S DISCLOSURE). PT CONSULTED EYE DOCTOR, INTRAOCULAR PRESSURE 45, TREATMENT WITH EYE DROPS, INFLAMMATION PERSISTING BASED ON PT'S INFO. LASER TREATMENT OF REDUCTION OF INTRAOCULAR PRESSURE PLANNED, ALTERNATIVE BY-PASS TREATMENT TO ALLOW EYE WASH TO DRAIN. ACCORDING TO DENTIST, ALLERGY ID CONTAINS CORTICOIDS, HORMONES, PAIN MEDICATION. PHONE CONVERSATION WITH PT AT A LATER DATE; THE EYE HAS BEEN LASERED, FEELS BETTER, ALLERGY TEST NOT PERFORMED YET AS MATERIAL CURES TOO FAST FOR THE TEST. ALLERGIST IS SEARCHING FOR DIFFERENT WAY TO APPLY THE MATERIAL AND WILL REPEAT THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XANTOPREN IMPRESSION MATERIAL ELW HERAEUS KULZER GMBH * *
    2 ACTIVATOR UNIVERSAL PLUS PASTE IMPRESSION MATERIAL COMPONENT ELW HERAEUS KULZER GMBH * 290329

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other