BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE IMPRESSION KIT

    MDR report key: 20588853 · Received November 1, 2024

    Report

    Report Number
    3014845255-2024-02326
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    November 1, 2024
    Manufacturer
    BLUE FUZION GROUP LIMITED
    Product Code
    OFX
    UDI-DI
    00850017524019
    Adverse Event
    Yes
    Report Source
    Distributor 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

    PATIENT REPORTED CHIPPING A TOOTH WHILE TAKING IMPRESSIONS. PATIENT HAD CHIP REPAIRED WITH A COMPOSITE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789786 BYTE IMPRESSION KIT GENERAL PURPOSE DENTAL TRAY OFX BLUE FUZION GROUP LIMITED KIT UNKNOWN 00850017524019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention