BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AER

    MDR report key: 405781 · Received July 19, 2002

    Report

    Report Number
    2084725-2002-00025
    Event Type
    Injury
    Date Received
    July 19, 2002
    Date of Event
    May 1, 2002
    Report Date
    July 19, 2002
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS WERE DIAGNOSED AS HAVING CHEMICAL COLITIS FOLLOWING PROCEDURES USING INSTRUMENTS DISINFECTED WITH UNITROL AUTOMATED SCOPE WASHERS USING CIDEX OPA. THE PATIENTS WERE HOSPITALIZED WITH RECTAL BLEEDING AND PAIN. THE REPORTER WAS NOT AWARE OF ANY TREATMENT. THE FACILITY HAS THREE UNITROL UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AER AUTOMATIC ENDOSCOPE REPROCESSOR KOG ADVANCED STERILIZATION PRODUCTS 20300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization