BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPOWER DUAL ENZYMATIC

    MDR report key: 1052884 · Received May 27, 2008

    Report

    Report Number
    MW5007046
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    June 11, 2007
    Report Date
    May 27, 2008
    Manufacturer
    METREX
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A SURGICAL TECHNOLOGIST WHO HAS BEEN DIAGNOSED WITH AN INJURY RESULTING IN PERMANENT PARTIAL DISABILITY BY WORK COMP QME DUE TO EXPOSURE TO A BIOCIDE -PHENONIP/PHENOXYETHANOL- USED IN AN INDUSTRIAL DETERGENT "EMPOWER DUAL ENZYMATIC" FROM METREX. THIS DETERGENT WAS ALSO PRODUCED UNDER A "STRYKER ENZYMATIC" LABEL BY METREX FOR STRYKER. THIS DETERGENT WAS USED TO CLEAN A MEDICAL DEVICE, THE "STRYKER NEPTUNE LIQUID WASTE MANAGEMENT SYSTEM" UNTIL JULY OF 2007 WHEN STRYKER SWITCHED TO A DIFFERENT DETERGENT. A MECHANIZED CLEANING PROCESS -STRYKER NEPTUNE DOCKING STATION- DUMPED THIS DETERGENT IN A HEATED STATE DOWN AN OPEN STANDPIPE TO A FLOOR SINK, RESULTING IN VAPOR AND AEROSOL GENERATION. AFTER DAILY EXPOSURE TO THIS DETERGENT FOR MANY MONTHS, I EXPERIENCED A "DISASSOCIATIVE INTOXICATION" AFTER CLEANING THESE MACHINES; AND LATER, CHRONIC NEUROLOGICAL SYMPTOMS WHICH HAVE YET TO FULLY RESOLVE. PHENOXYETHANOL IS A KNOWN NMDA DISRUPTER: "EFFECTS OF 2-PHENOXYETHANOL ON N-METHYL-D-ASPARATE-NMDA- RECEPTOR-MEDIATED ION CURRENTS" -PUBMED.GOV-; AND KNOWN TO CAUSE PERMANENT NEUROLOGICAL IMPAIRMENT: "OCCUPATIONAL PHENOXYETHANOL NEUROTOXICITY: A REPORT OF THREE CASES -MORTON WE-. A REPRESENTATIVE FROM CLARIANT, THE MANUFACTURER OF PHENONIP HAS TOLD ME THEIR PRODUCT -PHENONIP- IS SOLD ONLY AS A PRESERVATIVE FOR COSMETICS, AND IS NOT APPROVED FOR USE AS A DETERGENT BIOCIDE. A REPRESENTATIVE I WAS WORKING WITH FROM METREX CALLED ME BACK ON A CELL PHONE -AS THE METREX LINES ARE MONITORED- AND TOLD ME "YOU'RE NOT CRAZY, WE GET A LOT OF CALLS ON THIS PRODUCT". SOMEONE NEEDS TO STRAIGHTEN OUT METREX ON THE DANGERS OF USING PHENONIP/PHENOXYETHANOL AS A BIOCIDE IN A DETERGENT THAT IS USED IN A HEATED STATE! PLEASE HELP US IF YOU CAN. DATES OF USE: THREE YEARS, TWO MONTHS, 2004 -- 2007. DIAGNOSIS OR REASON FOR USE: CLEANING OF STRYKER NEPTUNE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPOWER DUAL ENZYMATIC LIQUID DETERGENT FOR MEDICAL/INDUSTRIAL USE LRJ METREX
    2 STRYKER ENZYMATIC LIQUID DETERGENT FOR MEDICAL/INDUSTRIAL USE LRJ STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention MANAGEMENT SYSTEM UNTIL| USED IN THE STRUKER NEPTUNE LIQUID WASTE