BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 DUAL CURE CLEAR

    MDR report key: 2222225 · Received August 24, 2011

    Report

    Report Number
    2024312-2011-00200
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    July 29, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT A PATIENT DEVELOPED HIVES AFTER VENEERS HAD BEEN PLACED WITH NX3. THE CONDITION WORSENED TO THE POINT THAT THE PATIENT WENT TO THE HOSPITAL FOR TREATMENT. WHEN THE OFFICE WAS CONTACTED, THE OFFICE ADMINISTRATOR MENTIONED THAT THE PATIENT HAD RECEIVED A (B)(6) TEST THE DAY BEFORE. THE DOCTOR'S OFFICE WAS LATER CONTACTED TO INQUIRE ON THE PATIENT'S CONDITION. THE OFFICE INDICATED THAT THE PATIENT HAD BEEN RELEASED FROM THE HOSPITAL AND WAS GOING TO BE SEEN BY A DOCTOR OF INTERNAL MEDICINE. THE INTERNIST DID NOT BELIEVE THE HIVES WERE RELATED TO THE NX3 PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED BY THE CUSTOMER AND NO INFORMATION WAS PROVIDED REGARDING THE PRODUCT PART OR LOT NUMBER; THEREFORE, NO EVALUATION CAN BE DONE. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR ALLEGED THAT AFTER PLACEMENT OF VENEER, PATIENT DEVELOPED HIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NX3 DUAL CURE CLEAR DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SILANE PRIMER