BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHODONTIC INVISIBLE ALIGNER

    MDR report key: 9196980 · Received October 15, 2019

    Report

    Report Number
    MW5090401
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 12, 2019
    Manufacturer
    SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PUT ORTHODONTIC ALIGNER IN THAT WAS MADE BY SMILE DIRECT CLUB AND IT HAD A PUBIC LIKE HAIR PROCESSED IN IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983712 ORTHODONTIC INVISIBLE ALIGNER ALIGNER, SEQUENTIAL NXC SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR