BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL BUR, SIZE 557

    MDR report key: 29096 · Received December 28, 1995

    Report

    Report Number
    MW4001001
    Event Type
    Malfunction
    Date Received
    December 28, 1995
    Report Date
    September 5, 1995
    Manufacturer
    L.D. CAULK CO.
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BUR HAS BEEN SHEARING OFF DURING ROUTINE USE. THE BUR BREAKS WHERE THE CUTTING EDGES MEET THE SHANK, AS WELL AS, IN THE MIDDLE OF THE BUR'S BURRING AREA. OFTEN SEVERAL BURS ARE REQUIRED FOR ONE PREPARATION. BURS WERE BREAKING RIGHT OUT OF THE PACKAGE (THEY WERE NOT STERILIZED). ON CONTRACT ACQUISITIONS OF 46,280 PACKAGES FACILITY RECEIVED ONLY TWO COMPLAINTS. FACILITY IS CONSIDERING SUBJECT COMPLAINTS ISOLATED INCIDENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL BUR, SIZE 557 DENTAL BUR EJL L.D. CAULK CO. 9503153089-665742

    Patients

    Seq Age Sex Outcome Treatment
    1 *