BEUDAMED
    FDA Adverse Event Summary report: N

    TONOMETRY

    MDR report key: 4777241 · Received May 8, 2015

    Report

    Report Number
    MW5042726
    Date Received
    May 8, 2015
    Report Date
    May 8, 2015
    Product Code
    HKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    (B)(6). I WOULD LIKE TO REPORT THAT TONOMETRY DEVICES CANNOT BE PROPERLY DISINFECTED. IT HAS BEEN DOCUMENTED THAT EBOLA CAN REMAIN LIVE IN PATIENT'S EYE. THERE IS NO WAY BECAUSE OF THE DESIGN OF THE TONOMETRY DEVICE THAT IT CAN BE PROPERLY DISINFECTED. IT HAS DIRECT CONTACT WITH PATIENT'S BODY FLUIDS, AND IS USED MULTIPLE TIMES A DAY WITHOUT PROPER DISINFECTING. I KNOW THAT THE FDA IS ACTIVELY INVOLVED IN REPRODUCING REUSABLE MEDICAL DEVICE ISSUES, AND WOULD RECOMMEND THAT THIS DEVICE ALSO BE EVALUATED. YOU WILL NOTICE IN THE PHOTOGRAPHS THAT THE OPHTHALMOLOGIST WAS NOT WEARING GLOVES WHILE EXAMINING THE PATIENT AND WOULD POTENTIALLY TOUCH BODY FLUIDS FROM PATIENTS' EYES. INSTRUMENT TOUCHES PATIENT'S EYE AS WELL WHICH HAD ACTIVE EBOLA VIRUS IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303029 TONOMETRY TONOMETRY HKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S