BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIREL IGN 500

    MDR report key: 11051 · Received January 13, 1994

    Report

    Report Number
    MW1000486
    Event Type
    Malfunction
    Date Received
    January 13, 1994
    Report Date
    December 28, 1993
    Manufacturer
    AIREL
    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 NEW PRODUCT TO THE DENTAL MARKET THAT CLAIMS TO PRODUCE "ASEPTICALLY PURE" WATER IN THE DENTAL UNIT. IT USES A SOLUTION CALLED CALBENIUM AS A BACTERIOSTATIC, BACTERIOCIDAL AND VIRUCIDAL AGENT THAT IS EFFECTIVE FOR 100 DAYS. THE LITERATURE FROM THE MFR SUGGESTS THE DENTAL UNIT WILL PRODUCE A STERILE SPRAY IF THE DEVICE IS USED WHICH IS SUITABLE FOR SURGERY. ACCORDING TO THE JADA, 10/93, AS WELL AS OTHER PUBLICATIONS DENTAL UNIT WATERLINES ARE HIGHLY CONTAMINATED WITH BACTERIA DUE TO THE PRESENCE OF A BIOFILM LINING THE TUBINGS. A DISINFECTANT SOLUTION WOULD NEED TO BE EXTREMELY POTENT TO REMOVE ALL BACTERIA FROM THE BIOFILM, AND IF THIS IS TRUE THE SOLUTION LIKELY WOULD PROVE TOXIC TO PTS. RPTR QUESTIONS IF THIS CALBENIUM SOLUTION HAS BEEN PROVEN NON-TOXIC AND HAS IT BEEN SHOWN TO REMOVE BIOFILM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIREL IGN 500 EKY AIREL

    Patients

    Seq Age Sex Outcome Treatment
    1 *