BEUDAMED
    FDA Adverse Event Summary report: N

    PROLYSTICA ULTRA CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

    MDR report key: 2531041 · Received April 12, 2012

    Report

    Report Number
    1937531-2012-00003
    Date Received
    April 12, 2012
    Date of Event
    March 14, 2012
    Report Date
    April 12, 2012
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THIS EVENT IS CURRENTLY UNDER INVESTIGATION; ADDITIONAL INFORMATION WILL BE PROVIDED AS AVAILABLE REGARDING THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE ROOM WHERE THE PROLYSTICA DOSING SYSTEM WAS LOCATED WAS REPORTED AS SMALL (3X9). THE USER FACILITY REPORTED THAT FREQUENCY OF AIR CHANGES IN THIS ROOM WERE INADEQUATE, RESULTING IN REDUCED VENTILATION; THE FACILITY HAS SUBSEQUENTLY CORRECTED THIS. THE USER FACILITY USES AN AQU SINQ DOSING SYSTEM TO DISPENSE THE PRODUCT FOR MIXING PURPOSES. THE STERIS CONSUMABLE MANAGER STATED THAT THE AQU SINQ DOSING SYSTEM WAS OPERATING PROPERLY. PPE IS REQUIRED FOR THE HANDLING OF THIS PRODUCT. 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 LABEL FURTHER STATES: "USE ADEQUATE VENTILATION TO MAINTAIN LEVELS BELOW ESTABLISHED EXPOSURE LIMITS." THE USER FACILITY HAS DISCONTINUED THE USE OF PROLYSTICA.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT 4 EMPLOYEES WORKING IN THE ANESTHESIA DEPARTMENT EXPERIENCED RASHES AFTER USING THE PRODUCT. ALL 4 EMPLOYEES REPORTED RASHES - 3 ON THEIR HANDS AND LOWER ARMS; ONE OVER THEIR ENTIRE BODY. THREE OF THE EMPLOYEES WERE USING THE PRODUCT TO MANUALLY CLEAN MEDICAL DEVICES IN A SINK AND THE 4TH EMPLOYEE WAS WORKING IN THE VICINITY OF THE OTHERS. THE USER FACILITY STATED THAT THE EMPLOYEES WERE WEARING PROPER PPE. THE 4 EMPLOYEES WERE EXAMINED IN THE (B)(6). IT WAS REPORTED THAT NO TREATMENT WAS GIVEN AND THE RASHES CLEARED UP WITHIN 24 HOURS. IT WAS ALSO REPORTED THAT THE EMPLOYEES HAVE 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