BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O3Z OZONE GENERATING SYSTEM

    MDR report key: 244887 · Received October 12, 1999

    Report

    Report Number
    3019131-1999-00002
    Event Type
    Injury
    Date Received
    October 12, 1999
    Date of Event
    September 9, 1999
    Report Date
    September 15, 1999
    Manufacturer
    OSMONICS KENT OPERATIONS
    Product Code
    KOC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SIX PTS ON HEMODIALYSIS EXPERIENCED ALLEGED PYROGENIC REACTIONS OR SYMPTOMS. ONE WAS HOSPITALIZED WITH FEVER. THE MEDICAL DIRECTOR ATTRIBUTED THE REACTIONS TO THE USE OF OZONE AS AN EQUIPMENT CLEANER AND DISINFECTANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R FRESENIUS F80M DIALYZER.