BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALODENT BITINE RING

    MDR report key: 492209 · Received October 29, 2003

    Report

    Report Number
    2515379-2003-00177
    Event Type
    Injury
    Date Received
    October 29, 2003
    Report Date
    September 30, 2003
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE BITINE RING SPRANG OFF OF A TOOTH BEING RESTORED AND FRACTURED AN ADJACENT TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALODENT BITINE RING DENTAL HAND INSTRUMENT EJG DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention