BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVS ONE STEP CLEANING AND DISINFECTING SOLUTION

    MDR report key: 520731 · Received April 8, 2004

    Report

    Report Number
    2438562-2004-00001
    Event Type
    Other
    Date Received
    April 8, 2004
    Date of Event
    September 1, 2003
    Report Date
    October 3, 2003
    Manufacturer
    SAUFLON PHARMACEUTICALS LTD
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED BAD BURNING AND REDNESS OF THE EYES, WENT TO THE DOCTOR AND WAS GIVEN EYE DROPS TO CLEAR THE REDNESS. PT ADMITTED NOT ALLOWING THEIR LENSES TO SOAK FOR SIX HOURS BEFORE THEY INSERTED THEM INTO THEIR EYES AND NOT READING THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 CVS ONE STEP CLEANING AND DISINFECTING SOLUTION CLEANING AND DISINFECTING LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS LTD * 56221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other