BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O3Z OZONE GENERATING SYSTEM

    MDR report key: 277446 · Received May 10, 2000

    Report

    Report Number
    3019131-2000-00011
    Event Type
    Injury
    Date Received
    May 10, 2000
    Date of Event
    May 8, 2000
    Report Date
    May 10, 2000
    Manufacturer
    OSMONICS, INC. KENT OPERATIONS
    Product Code
    FIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A DISINFECTANT TRAINING SESSION FOR THE OZONE SYSTEM AT A DIALYSIS FACILITY THREE TRAINEES COMPLAINED OF DIZZINESS. THEY WERE TRANSPORTED TO AN EMERGENCY ROOM FOR EVAL. TWO OF THE TRAINEES WERE SENT HOME FROM WORK AND ONE RETURNED TO WORK. THE REPORTER SAID THAT THE ROOM FAN WAS NOT WORKING OR WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O3Z OZONE GENERATING SYSTEM OZONE GENERATOR, 2.3G/HR FIP OSMONICS, INC. KENT OPERATIONS 14651 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization