BEUDAMED
    FDA Adverse Event Summary report: N

    PROLYSTICA ULTRA CONCRENTRATE ENZYMATIC PRESOAK AND CLEANER

    MDR report key: 2222172 · Received August 24, 2011

    Report

    Report Number
    1937531-2011-00003
    Date Received
    August 24, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE EVENT IS AN ALLERGIC REACTION TO THE PRODUCT. THE LABELING OF THE PRODUCT STATES "WARNING: CONTAINS SUBTILISINS (PROTEOLYTIC ENZYME). IRRITATING TO EYES AND SKIN. PROLONGED OR FREQUENTLY REPEATED CONTACT TO SUBTILISINS MAY CAUSE ALLERGIC REACTION IN SOME INDIVIDUALS." EMPLOYEE HEALTH IS CHANGING THE EMPLOYEE'S WORK DUTIES SO THAT SHE IS NO LONGER IN CONTACT WITH THE PRODUCT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE IN THE ENDOSCOPE CLEANING ROOM EXPERIENCED AN ALLERGIC REACTION AFTER PROLONGED EXPOSURE TO PROLYSTICA ENZYMATIC PRESOAK AND CLEANER. THE REACTION WAS REDNESS, ITCHINESS, A RASH AROUND HER EYES, COUGHING, AND WHEEZING. THIS REPORTED EVENT OCCURRED AFTER THE EMPLOYEE WORKED A FULL DAY IN CONTACT WITH THE PRODUCT. UPON THE FIRST ALLERGIC REACTION, THE EMPLOYEE REPORTED TO EMPLOYEE HEALTH AND A DOCTOR PRESCRIBED EYE DROPS AND STEROIDS. THE EMPLOYEE CONTINUED TO EXPERIENCE AN ALLERGIC REACTION AND SELF MEDICATED. THE EMPLOYEE AGAIN SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED ADDITIONAL EYE DROPS AND STEROIDS. THE EMPLOYEE IS REPORTED TO HAVE OTHER ALLERGIES INCLUDING LATEX AND FOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other