BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEAKMAN EYMEDIC SE-4270 SINGLE USE CONTAINER WATER, USP

    MDR report key: 591899 · Received March 28, 2005

    Report

    Report Number
    MW1035154
    Event Type
    Malfunction
    Date Received
    March 28, 2005
    Date of Event
    March 17, 2005
    Report Date
    March 23, 2005
    Manufacturer
    SPEAKMAN
    Product Code
    LWD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN RESEARCHING EMERGENCY EYE WASH SOLUTIONS FOR A COMPANY RPTR HAD THIS PRODUCT SENT OUT FOR MICROBIAL TESTING. THE TEST RESULT CAME BACK WITH A COUNT FOR BACTERIAL PLATE COUNT OF 73000 CFU/ML (TOO NUMEROUS TO COUNT). THE ONLY INGREDIENT IN THE PRODUCT WAS PURIFIED WATER, NO PRESERVATIVES AND IT WAS NOT MARKETED AS STERILE. PRODUCT DID NOT HAVE A LOT NUMBER AND COMPANY WAS NOT ON THE FDA REGISTRATION DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEAKMAN EYMEDIC SE-4270 SINGLE USE CONTAINER WATER, USP SINGLE DOSE EMERGENCY EYEWASH FLUSHING FLUID LWD SPEAKMAN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other