BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYCAMORE WOOD WEDGES

    MDR report key: 24384680 · Received February 18, 2026

    Report

    Report Number
    2511556-2026-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 18, 2026
    Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY
    Product Code
    JEP
    UDI-DI
    00348783005059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    WE RECEIVED A COMPLAINT FOR DENTAL OFFICE STATING THAT THE BLUE DYE IN WEDGE APPEARED TO STAIN A PATIENT'S GUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445609 SYCAMORE WOOD WEDGES RETAINER, MATRIX JEP PREMIER DENTAL PRODUCTS COMPANY KR5662 00348783005059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other