BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE RETAINER

    MDR report key: 20258608 · Received September 19, 2024

    Report

    Report Number
    3014845255-2024-01100
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    KMY
    UDI-DI
    00850017524187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 0

    WHILE USING A BYTE RETAINERS, PATIENT REPORTED THAT THEY HAVE BLISTER AND IRRITATION ON THEIR GUMS IN THE AREA OF THEIR TWO FRONT TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672557 BYTE RETAINER POSITIONER, TOOTH, PREFORMED KMY STRAIGHT SMILE, LLC BYTERETAINER 00850017524187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention