BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARBY

    MDR report key: 20651245 · Received November 11, 2024

    Report

    Report Number
    3003444492-2024-00003
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 24, 2024
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE OF RETURNED DEVICES WERE TESTED FOR NECK STRENGTH AND ALL DEVICES PASSED THE REQUIRED SPECIFICATION.

    Description of Event or Problem · 0

    DARBY - 9525118/010PK CARBIDE BURS FG 4P - LOT 1182470 - BURS ARE BEING RETURNED FROM A CUSTOMER BECAUSE THE BURS ARE BREAKING. RETURN OF 59 PACKS OF 10 BURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944819 DARBY FG 4P - 9525118 EJL PRIMA DENTAL GROUP CPEARS014FG170D 1182470

    Patients

    Seq Age Sex Outcome Treatment
    1 123 YR Unknown