BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SS WHITE DENTAL BURR

    MDR report key: 21700716 · Received March 26, 2025

    Report

    Report Number
    MW5168269
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 20, 2025
    Report Date
    March 21, 2025
    Manufacturer
    SS WHITE BURS LLC.
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BUR EJECTED OUT OF HANDPIECE DURING APPOINTMENT. CAUSED SMALL GINGIVAL LACERATION. HANDPIECE SET ASIDE AND BUR REMOVED. 330 BUR LOT: S18047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415643 SS WHITE DENTAL BURR BUR, DENTAL EJL SS WHITE BURS LLC. 330 S18047

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown