BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAULK TOOTH CONDITIONER GEL 34%

    MDR report key: 484870 · Received September 16, 2003

    Report

    Report Number
    2515379-2003-00124
    Event Type
    Malfunction
    Date Received
    September 16, 2003
    Date of Event
    August 11, 2003
    Report Date
    August 18, 2003
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED WHILE EXTRUDING TOOTH CONDITIONER GEL THE TIP CAME OFF AND THE MATERIAL WENT INTO THEIR EYE. THE DOCTOR IMMEDIATELY RINSED THE EYE WITH WATER AND THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAULK TOOTH CONDITIONER GEL 34% PIT & FISSURE SEALANT AND CONDITIONER EBC DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other