BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARGO

    MDR report key: 191490 · Received October 13, 1998

    Report

    Report Number
    MW1014716
    Event Type
    Malfunction
    Date Received
    October 13, 1998
    Report Date
    October 13, 1998
    Manufacturer
    G.P. SPECIALISTS, INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT PT'S RESPONSE TO APPROVED LENS IS INFERIOR TO THEIR RESPONSE TO THE UNAPPROVED, INVESTIGATIONAL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FARGO CONTACT LENS LPL G.P. SPECIALISTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA