BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER

    MDR report key: 4847546 · Received June 16, 2015

    Report

    Report Number
    1937531-2015-00005
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 1, 2015
    Report Date
    November 15, 2019
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY CONTACTED CHEMTREC FOR ADVICE AND MEDICAL ASSISTANCE. CHEMTREC CONTACTED THE ROCKY MOUNTAIN POISON AND DRUG CENTER FOR IMMEDIATE MEDICAL ASSISTANCE. THE PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER LABEL CLEARLY STATES, "WARNING: CONTAINS SUBTILISINS (PROTEOLYTIC ENZYME)(CAS#9014-01-1). IRRITATING TO EYES AND SKIN. PROLONGED OR FREQUENTLY REPEATED CONTACT TO SUBSTILISINS MAY CAUSE ALLERGIC REACTION IN SOME INDIVIDUALS. WEAR PROTECTIVE EYEWEAR AND GLOVES." STERIS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER THE USER FACILITY WILL NOT RESPOND.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PATIENT SUFFERED EYE EXPOSURE TO PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390089 PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER CLEANER FLG STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1