BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 12925794 · Received December 3, 2021

    Report

    Report Number
    3014658399-2021-01506
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 11, 2020
    Report Date
    December 3, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    NXC
    PMA / PMN Number
    K191990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED BY THE PATIENT, THERE IS NO CONCLUSIVE EVIDENCE THAT SUPPORTS OR OPPOSES THE FACT THAT THE ALIGNERS CAUSED, CONTRIBUTED, OR WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED SYMPTOMS OR PHYSIOLOGICAL CONDITIONS SIMILAR TO AN ALLERGIC REACTION. AS PER CAPA #(B)(4) THIS EVENT IS RETROSPECTIVELY BEING REPORTED AND THEREFORE WAS NOT REPORTED WITHIN THE REQUIRED 30-DAYS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DIFFICULTY BREATHING AND SWELLING WHILE WEARING THE ALIGNERS. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826969 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown Other