BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON CLEAR DEBONDING PLIER

    MDR report key: 12668562 · Received October 20, 2021

    Report

    Report Number
    2016150-2021-00005
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    October 20, 2021
    Product Code
    JEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A ROOT CANAL AND A TEMPORARY CROWN PLACED AND CURRENTLY THE PATIENT IS DOING WELL JUST HAS SOME MILD DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS ALLEGEDLY REPORTED THAT DAMON CLEAR DEBONDING PLIER FRACTURED THE PATIENTS TOOTH WHILE REMOVING A DQ2 CLEAR BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567156 DAMON CLEAR DEBONDING PLIER DAMON CLEAR DEBONDING PLIER JEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other