BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB IMPRESSION KIT

    MDR report key: 12802737 · Received November 12, 2021

    Report

    Report Number
    3014658399-2021-01339
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    September 11, 2020
    Report Date
    November 12, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    ELW
    PMA / PMN Number
    K092319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    ON (B)(6) 2020 THE CUSTOMER REPORTED AN ALLERGIC REACTION WHILE WEARING THE ALIGNERS. MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705775 SMILEDIRECTCLUB IMPRESSION KIT IMPRESSION KIT ELW ACCESS DENTAL LAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown Other