BEUDAMED
    FDA Adverse Event Summary report: N

    PROLYSTICA ULTRA CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

    MDR report key: 2655117 · Received July 13, 2012

    Report

    Report Number
    1937531-2012-00005
    Date Received
    July 13, 2012
    Date of Event
    June 7, 2012
    Report Date
    July 13, 2012
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY USES AN ACU-SINQ DOSING SYSTEM TO DISPENSE THE PRODUCT. THE STERIS ACCOUNT MANAGER STATED THAT THE ACU-SINQ DOSING SYSTEM WAS OPERATING PROPERLY. PRODUCT LABELING STATES: "WARNING: CONTAINS SUBTILISINS (PROTEOLYTIC ENZYME) (CAS# 9014-01-1) IRRITATING TO EYES AND SKIN. PROLONGED OR FREQUENTLY REPEATED CONTACT TO SUBTILISINS MAY CAUSE ALLERGIC REACTION IN SOME INDIVIDUALS. DO NOT GET IN EYES, ON SKIN OR CLOTHING. WEAR PROTECTIVE EYEWEAR AND GLOVES. DO NOT BREATHE MIST SPRAY." THE USER FACILITY HAS SINCE DISCONTINUED THE USE OF PROLYSTICA.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE HAD DIFFICULTY BREATHING AND COUGHING WHILE USING PROLYSTICA. THREE OTHER EMPLOYEE REPORTED HEADACHES WHILE USING THE PRODUCT. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WENT TO EMPLOYEE HEALTH FOR A WORK RELATED ILLNESS; NO MEDICATION WAS ADMINISTERED. THE EMPLOYEE MISSED NO TIME FROM WORK AND IS FINE WITH NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLYSTICA ULTRA CONCENTRATE ENZYMATIC PRESOAK AND CLEANER DISINFECTANT LRJ STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other