BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIZILITE PRO

    MDR report key: 7768247 · Received August 8, 2018

    Report

    Report Number
    MW5078943
    Event Type
    Injury
    Date Received
    August 8, 2018
    Report Date
    August 6, 2018
    Manufacturer
    DEN-MAT HOLDINGS LLC
    Product Code
    NXV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI, I WENT TO (B)(6), FOR MY DENTAL APPT. I GOT VIZILITE PRO, ORAL LESION SCREENING SYSTEM TO SCREEN CANCER. I AM NOT SURE IF THIS INSTRUMENT WAS FDA/CDRH CLEARED / APPROVED. ANYWAY, AS TODAY THREE DAYS LATER, I STILL FEEL MY TONGUE WAS BURNT, NOT COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606499 VIZILITE PRO VIZILITE PRO NXV DEN-MAT HOLDINGS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other