BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERR CORPORATION TRIMMING & FINISHING CARBIDE BURS

    MDR report key: 21275762 · Received January 30, 2025

    Report

    Report Number
    MW5165443
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 24, 2025
    Report Date
    January 24, 2025
    Manufacturer
    KERR CORPORATION
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSUFFICIENT INSTRUCTIONS FOR USE (IFUS). HEALTH CARE PROFESSIONALS ARE NOT ABLE TO APPROPRIATELY CLEAN/DECONTAMINATE KERR DENTAL BURS DUE TO THERE BEING CONTRADICTING INSTRUCTIONS, AS WELL AS INSUFFICIENT INSTRUCTIONS IN THEIR IFUS. THE IFUS ARE AVAILABLE WITH THE PRODUCTS AND THROUGH THE COMPANY, BUT THE TERM "BUR" WITH "KERR" "CORPORATION" ONLY PROVIDES RESULTS FOR "DRILLS' INT EH NATIONAL LIBRARY OF MEDICINE GUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519222 KERR CORPORATION TRIMMING & FINISHING CARBIDE BURS BUR, DENTAL EJL KERR CORPORATION ENDO ZKFG-KC0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown