BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 446540 · Received March 6, 2003

    Report

    Report Number
    MW1027733
    Event Type
    Injury
    Date Received
    March 6, 2003
    Date of Event
    February 20, 2003
    Report Date
    March 6, 2003
    Manufacturer
    MIDWEST EYE LABORATORIES
    Product Code
    HQT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER WEARS PROTECTIVE LENS WHICH THEY DESCRIBE AS A THIN SHELL OVER AN EXISTING EYE INJURY. WHILE WAITING IN THE OFFICE TO HAVE THIS LENS PAINTED, THEY STARTED SNEEZING FROM STRONG PAINT SMELL. AFTER WEARING LENS FOR 2 DAYS, STILL WAS SNEEZING AND NOW COUGHING, HAD LOWER BACK PAIN AND BLOODY STOOLS. WENT TO CHIROPRACTOR WHO SAID THEIR BACK PAIN MAY BE DUE TO KIDNEY PROBLEMS. CALLER IS CURRENTLY NOT USING LENS TO SEE IF SYMPTOMS GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROTECTIVE LENS HQT MIDWEST EYE LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR