BEUDAMED
    FDA Adverse Event Summary report: N

    RENU

    MDR report key: 713549 · Received May 10, 2006

    Report

    Report Number
    MW1039074
    Date Received
    May 10, 2006
    Date of Event
    February 20, 2006
    Report Date
    April 28, 2006
    Manufacturer
    *
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VIVAL ULCER OF RIGHT CORNEA. QUESTIONABLY RELATED TO SCL USE WITH HISTORY OF OCCASIONAL EXTENDED WEAR. NOT LIKELY THIS WAS FUSARIUM CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU * LPN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR