BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "WATER FIXER" UV WATER STERILIZER

    MDR report key: 11050 · Received January 12, 1994

    Report

    Report Number
    MW1000479
    Event Type
    Malfunction
    Date Received
    January 12, 1994
    Report Date
    December 28, 1993
    Manufacturer
    WATER TECHNOLOGY DIV. THE CSH GROUP, INC.
    Product Code
    EKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IS A STERILIZER UNIT THAT IS ATTACHED TO THE WATER SOURCE IN DENTAL UNITS. THE LITERATURE THAT IS SUPPLIED BY THE MFR CITES AEROSOLIZED WATER FROM THE DENTAL UNIT HANDPIECE AND 3-WAY SYRINGE AS A SOURCE OF INFECTION FOR DENTAL PERSONNEL AS WELL AS PTS. ACCORDING TO THE JADA, 10/93, AS WELL AS NUMEROUS OTHER REPORTS IN THE LITERATURE, THE MAJOR SOURCE OF BACTERIAL CONTAMINATION OF DENTAL UNIT WATERLINES IS THE BIOFILM THAT FORMS ON THE INSIDE OF THE TUBING WHICH THE DEVICE DOES NOTHING TO ELIMINATE. THE MFR SUGGESTS CONNECTING THE DEVICE TO THE DENTAL UNIT WATER SOURCE TO ELIMINATE BACTERIA AND VIRUSES IN AEROSOLS. ACCORDING TO RPTR THIS SIMPLY DOES NOT WORK. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "WATER FIXER" UV WATER STERILIZER EKY WATER TECHNOLOGY DIV. THE CSH GROUP, INC. 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 *