BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIZILITE PLUS

    MDR report key: 3437200 · Received October 24, 2013

    Report

    Report Number
    1646353-2013-00001
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ZILA, INC
    Product Code
    EAZ
    PMA / PMN Number
    K033033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS NOT RETURNED TO THE MANUFACTURER THEREFOR A FORMAL EVALUATION WAS NOT CONDUCTED. HOWEVER, NO OTHER SIMILAR ADVERSE EVENTS FOR VISILITE PLUS HAVE BEEN REPORTED TO THIS MANUFACTURER. IT IS SUSPECTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO SOME INGREDIENT COMPONENT OF THE VIZILITE PLUS (HENCE THE DENTAL HYGIENIST PROVIDED THE CALLER WITH THE INGREDIENT INFORMATION FROM THE PRODUCT LABELING) AS PATIENT WAS BEING TREATED WITH AN ANTI-INFLAMMATORY (STEROIDS) AND AN ANTI-HISTAMINE (BENADRYL).

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A DENTAL HYGIENIST VIA PHONE ON (B)(6) 2013. THE HYGIENIST PERFORMED A ROUTINE TEETH CLEANING OF A PATIENT THE MORNING OF (B)(6) 2013. SHE ALSO HAD A PRE-CANCER SCREENING PERFORMED WITH THE VIZLITE PLUS, BUT SHE ONLY REQUIRED THE INITIAL ORAL ACETIC ACID RINSE. SINCE THE PRELIMINARY SCREEN WITH THE ACETIC ACID RINSE WAS NEGATIVE, THEY DID NOT NEED TO USE THE VIZLITE PLUS ORAL DYE. OVERALL, THE PATIENT'S DENTAL EXAM WAS UNREMARKABLE. ON (B)(6) 2013 THE DENTAL HYGIENIST WAS CONTACTED BY A FAMILY MEMBER OF THE PATIENT WHO REPORTED THAT THE PATIENT NEEDED TO BE HOSPITALIZED AFTER DEVELOPING LIP SWELLING AND INTERIOR CHEEK BURNING. FROM THE REPORT IT WAS UNCLEAR WHEN THE PATIENT'S SYMPTOMS BEGAN, IF THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL OR WHAT TREATMENTS WERE INSTITUTED. THE PATIENT'S FAMILY MEMBER WAS PROVIDED INGREDIENT INFORMATION FROM THE VIZLITE PLUS LABELING TO PROVIDE TO THE PATIENT'S TREATING PHYSICIAN. THE CALLER ALSO NOTED THAT THE PATIENT DID DECIDE ON (B)(6) 2013 THAT SHE WAS GOING TO USE A TEETH WHITENING PRODUCT, BUT THE CALLER WAS UNSURE IF THIS PRODUCT WAS EVER USED PRIOR TO THE ONSET OF HER COMPLICATIONS. ON (B)(6) 2013 A ZILA SALES REPRESENTATIVE'S REPORTED THAT THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE EVENT AND REMAINS HOSPITALIZED. THE SALES REPRESENTATIVE ALSO REPORTED THE PATIENT WAS BEING TREATED WITH BENADRYL AND STEROIDS. A MESSAGE WAS LEFT WITH THE DENTAL HYGIENIST ON (B)(6) 2013 REQUESTING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546365 VIZILITE PLUS EAZ ZILA, INC 242019

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization