BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL COMPOSITE BLUE LIGHT

    MDR report key: 11723760 · Received April 23, 2021

    Report

    Report Number
    MW5100980
    Event Type
    Injury
    Date Received
    April 23, 2021
    Report Date
    April 22, 2021
    Manufacturer
    UNK
    Product Code
    EBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TISSUE DAMAGE; (B)(6) (EFFECTS OF BLUE-LIGHT IRRADIATION DURING DENTAL TREATMENT) AND (BLUE LIGHT HAZARD IN DENTISTRY). THIS WAS APPROVED BY U.S. UNACCEPTABLE. I AM CLOSE TO DEATH FROM THIS. SAVE THE WORLD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614413 DENTAL COMPOSITE BLUE LIGHT ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| O| R| S