BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT

    MDR report key: 910310 · Received October 29, 2004

    Report

    Report Number
    2515379-2004-00480
    Event Type
    Malfunction
    Date Received
    October 29, 2004
    Date of Event
    September 30, 2004
    Report Date
    September 30, 2004
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE WAS NO INJURY REPORTED IN THIS CASE, A PREVIOUS REPORT WAS FILED PERTAINING TO IRREVERSIBLE DAMAGE TO A TOOTH REQUIRING INTERVENTION, THEREBY ESTABLISHING THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT IS REPORTABLE. FURTHER TESTING WILL BE PERFORMED ON THE RETURNED DEVICE AND RESULTS WILL BE REPORTED AS THEY BECOME AVAILABLE. RESULTS OF THE DHR REVIEW ARE ATTACHED.

    Description of Event or Problem · 1

    DOCTOR REPORTED A MALFUNCTION OF RING PLACEMENT FORCEPS CAUSED RING TO FALL INTO PATIENT'S MOUTH. PATIENT DID NOT SWALLOW RING AND THERE IS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALODENT SECTIONAL MATRIX SYSTEM, PLACEMENT FORCEPS EJG DENTSPLY CAULK NA 040126 (INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 YR