BEUDAMED
    FDA Adverse Event Summary report: N

    VALSURE DETERGENT

    MDR report key: 2508273 · Received March 28, 2012

    Report

    Report Number
    1937531-2012-00002
    Date Received
    March 28, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 28, 2012
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VALSURE NEUTRAL DETERGENT IS A NEUTRAL PH LIQUID DETERGENT DILUTED IN WATER; PRODUCT LABELING STATES: "WARNING - CAUSES SKIN AND EYE IRRITATION. DO NOT GET IN EYES, ON SKIN OR ON CLOTHING. WEAR PROTECTIVE EYEWEAR AND GLOVES. WASH THOROUGHLY AFTER HANDLING." THE USER FACILITY HAS DISCONTINUED USE OF THE PRODUCT PENDING INVESTIGATION BY STERIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED REDNESS ON THEIR SKIN AND SWELLING OF THEIR EYES DURING USE OF THE PRODUCT FOR MANUAL INSTRUMENT CLEANING. THE EMPLOYEE WENT TO THE FACILITY EMERGENCY ROOM WHERE THEY WERE GIVEN BENADRYL. THE EMPLOYEE IS FINE WITH NO SUSTAINING INJURIES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE EMPLOYEE WAS WEARING PPE PER DEPARTMENT POLICY AT THE TIME OF THE EVENT. THE MOST LIKELY CAUSE OF THE EMPLOYEE'S REACTION IS SENSITIVITY TO THE PRODUCT INGREDIENTS, A KNOWN POTENTIAL REACTION TO PRODUCT EXPOSURE LISTED ON THE PRODUCT LABELING. THE USER FACILITY HAS DISCONTINUED USE OF NEUTRAL DETERGENTS SUCH AS VALSURE AND SWITCHED TO USE OF ENZYMATIC DETERGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALSURE DETERGENT DISINFECTANT LRJ STERIS CORPORATION 260534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other