BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARBY

    MDR report key: 18414598 · Received December 28, 2023

    Report

    Report Number
    3007007357-2023-00013
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    November 17, 2023
    Report Date
    December 28, 2023
    Manufacturer
    HANDPIECE HEADQUARTERS
    Product Code
    EFB
    UDI-DI
    00889813025635
    PMA / PMN Number
    K080682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HEAD PART OF HANDPIECE EXPLODED INSIDE THE PATIENT'S MOUTH WHILE BEING USED DURING A TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402001 DARBY HANDPIECE EFB HANDPIECE HEADQUARTERS SUPER TRAC PLUS PUSH BUTTON 4 HOLE 00889813025635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other