BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT SURE OF THE BRAND NAME OF THE CONTACTS

    MDR report key: 563426 · Received November 2, 2004

    Report

    Report Number
    MW1034069
    Event Type
    Injury
    Date Received
    November 2, 2004
    Date of Event
    February 4, 2004
    Report Date
    November 2, 2004
    Manufacturer
    *
    Product Code
    LPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR BOUGHT A PAIR OF COSMETIC CONTACT LENSES FROM THE BUSINESS. RPTR HAS NEVER BEEN FITTED FOR CONTACT LENSES, NOR HAVE THEY EVER WORN CONTACT LENSES OF ANY KIND. RPTR WAS ADVISED THAT THERE WAS NO MEASUREMENT NEEDED FOR THE CONTACT LENSES. AFTER WEARING THE CONTACT LENSES RPTR DEVELOPED, WHAT WAS LATER DIAGNOSED AS CONTACT LENSES KERATITIS. THIS CO WAS NOT TRAINED OR LICENSED TO SELL THESE CONTACTS. RPTR DID NOT KNOW THIS AT THE TIME OF PURCHASE. THIS EVENT HAS ALSO BEEN DIRECTED TO THE DEPT OF HEALTH, THE BETTER BUSINESS BUREAU, THE ATTORNEY GENERAL OF STATE, AND THE DEPT OF STATE SVS -DRUGS AND MEDICAL DEVICES UNIT-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT SURE OF THE BRAND NAME OF THE CONTACTS COSMETIC CONTACT LENSES LPM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention