BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENU MULTIPLUS

    MDR report key: 2044279 · Received April 6, 2011

    Report

    Report Number
    MW5020114
    Event Type
    Other
    Date Received
    April 6, 2011
    Date of Event
    June 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    B & L
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTACT LENS/SOLUTION ASSOCIATED INFILTRATIVE KERATOCONJUNCTIVITIS. PATIENT PRESENTED WITH MULTIPLE CORNEAL INFILTRATES, PAIN, REDNESS AND DECREASED VISION. #1: DOSE OR AMOUNT: SOLUTION, FREQUENCY: NIGHTLY, ROUTE: TOPICAL. #2: DOSE OR AMOUNT: CONTACT LENS, FREQUENCY: DAILY, ROUTE: TOPICAL. DATES OF USE: (B)(6) 2010. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS SOLUTION LPN B & L
    2 NIGHT AND DAY CONTACT LENS LPM CIBA VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other