BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 218272 · Received April 8, 1999

    Report

    Report Number
    2429304-1999-00003
    Event Type
    Other
    Date Received
    April 8, 1999
    Date of Event
    March 11, 1999
    Report Date
    March 15, 1999
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIRST PT THAT WAS SCOPED WITH A SCOPE DISINFECTED WITH THE BRAND NEW AUTOMATIC DISINFECTOR PRESENTED THE NEXT DAY WITH WHAT THE DR DIAGNOSED AS CIDEX INDUCED COLITIS. THE PT WAS TREATED WITH ANTIBIOTICS BUT WAS NOT REQUIRED TO REMAIN IN THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ADAPTER TUBING KIT KOG OLYMPUS AMERICA, INC. 50303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other