BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS 20 STERILANT CONCENTRATE

    MDR report key: 288228 · Received August 4, 2000

    Report

    Report Number
    1527821-2000-00022
    Event Type
    Other
    Date Received
    August 4, 2000
    Date of Event
    July 6, 2000
    Report Date
    August 4, 2000
    Manufacturer
    STERIS CORP.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE OPERATOR WAS PREPARING TO INSERT A CUP OF STERIS 20 STERILANT CONCENTRATE FOR USE IN THE STERIS SYSTEM 1 PROCESSOR AND NOTICED THAT THE CUP CONTAINED HARD BUFFER POWDERS. THE OPERATOR ATTEMPTED TO LOOSEN THE BUFFER POWDERS BY MASSAGING THE CUP. REPORTEDLY, THE ACTIVE INGREDIENT, PERACETIC ACID (PAA), SQUIRTED OUT AND SPLASHED ONTO THE EYE, FACE, AND NECK OF A BYSTANDER. THE AFFECTED AREAS WERE IMMEDIATELY FLUSHED WITH WATER, AND AN EXAMINATION BY A MEDICAL OFFICER WAS CONDUCTED. THREE (3) SMALL, MINOR CHEMICAL BURNS RESULTED; NO MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS 20 STERILANT CONCENTRATE STERILE PROCESSING SYSTEM FLE STERIS CORP. NA A818-00322

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other