BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTHET-X HD

    MDR report key: 2032265 · Received March 23, 2011

    Report

    Report Number
    2515379-2011-00006
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBF
    PMA / PMN Number
    K984387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE ESTHETX-HD 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 MEETS CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. 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

    IN THIS EVENT, IT WAS REPORTED THAT A PATIENT EXPERIENCED NUMBNESS OF HER LIP IN THE AREA WHERE A RESTORATION WAS DONE THAT INVOLVED THE USE OF XENO IV ADHESIVE, ESTHETX-HD COMPOSITE. THE PATIENT WAS SENT TO AN ALLERGIST WITH A TOPICAL GEL AND LIDOCAINE USED DURING THE PROCEDURE TO DETERMINE IF SHE HAD AN ADVERSE REACTION TO THESE PRODUCTS. THE TEST CAME BACK NEGATIVE AND THE PATIENT SUBSEQUENTLY RETURNED TO THE OFFICE AFTER TWO WEEKS, THIS TIME COMPLAINING THAT BOTH HER TOP AND BOTTOM LIPS WERE NUMB ON THE LEFT SIDE WHERE THE PROCEDURE HAD BEEN COMPLETED. THE TREATING DENTIST AGAIN REFERRED HER TO THE ALLERGIST WITH SAMPLES OF THE XENO IV ADHESIVE AND ESTHETX-HD COMPOSITES. AS OF THIS MDR EVALUATION, THE REPORT HAD NOT YET BEEN RECEIVED DETERMINING IF SHE WAS ALLERGIC TO EITHER OF THE DENTSPLY MATERIALS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTHET-X HD EBF DENTSPLY CAULK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN TOPICAL GEL| LIDOCAINE