BEUDAMED
    FDA Adverse Event Summary report: N

    PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT

    MDR report key: 6042590 · Received October 19, 2016

    Report

    Report Number
    1937531-2016-00002
    Date Received
    October 19, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 19, 2016
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED THAT PRIOR TO THE REPORTED EVENT, THE INSTRUMENTS WERE SOAKED WITH PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT. FOLLOWING THE REPORTED EVENT, A STERIS CONSUMABLE MANAGER ARRIVED ONSITE AND PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND HANDLING OF PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT, SPECIFICALLY THE CORRECT METHOD FOR PRODUCT DILUTION, RINSING OF INSTRUMENTS AFTER SOAKING, AND VISUAL INSPECTION OF INSTRUMENTS AFTER RINSING. THE PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT PRODUCT LABEL STATES: "FILL SINK OR BASIN WITH WARM WATER TO THE APPROPRIATE LEVEL TO FULLY IMMERSE SURGICAL INSTRUMENTS. DILUTE CHEMISTRY AT 1/8 TO 1/2 FL. OZ. PER GALLON OF WARM WATER DEPENDING ON WATER QUALITY AND SOIL LOAD. SOAK FOR A MINIMUM OF 1-5 MINUTES." "ALL SURFACES SHOULD BE THOROUGHLY RINSED WITH WARM WATER. SOLUTIONS SHOULD BE DISCARDED DAILY OR WHEN VISIBLY SOILED."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT TWO PATIENTS EXPERIENCED EYE IRRITATION FOLLOWING A PROCEDURE. THE PATIENTS WERE PRESCRIBED STEROID EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692648 PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT NEUTRAL DETERGENT FLG STERIS CORPORATION 280873

    Patients

    Seq Age Sex Outcome Treatment
    1