BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL BURR

    MDR report key: 21764996 · Received April 3, 2025

    Report

    Report Number
    MW5168588
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 1, 2025
    Manufacturer
    UNKNOWN
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BUR WAS FULLY ENGAGED IN HANDPIECE PRIOR TO STARTING TREATMENT AND RAN HANDPIECE TO CONFIRM. NEARLY COMPLETED PREP BUR BEGAN TO SLIP OUT OF HANDPIECE. BUR NUMBER 169 - LOT L04L / EXP 2028-12-06. PREP WAS SUFFICIENT TO FIT CROWN, SO DID NOT NEED TO OBTAIN NEW BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333651 DENTAL BURR BUR, DENTAL EJL UNKNOWN BUR #169 LO04L

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown