BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM

    MDR report key: 2078666 · Received April 29, 2011

    Report

    Report Number
    MW5020475
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    DISCUS DENTAL LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTREME LIP SWELLING/BURN AND DISFIGURED APPEARANCE POST ZOOM TEETH - WHITENING PROCEDURE PERFORMED APPROXIMATELY BETWEEN THE HOURS OF 1145-130PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM ZOOM EEG DISCUS DENTAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention ZOOM TEETH WHITENING PERFORMED