BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCU-FILM

    MDR report key: 633959 · Received August 17, 2005

    Report

    Report Number
    633959
    Event Type
    Malfunction
    Date Received
    August 17, 2005
    Date of Event
    August 1, 2005
    Report Date
    August 17, 2005
    Manufacturer
    MEDTRONIC OPHTHALMICS: A DIVISION OF MEDTRONIC XOMED, INC.
    Product Code
    KYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OCU-FILM IS A TRANSPARENT, ELASTIC COVER FOR OPHTHALMIC PEN LIGHTS. WHEN THE 2 BOXES WERE OPENED, THE COVERS WERE BRITTLE AND DETERIORATED WITH YELLOW SPOTS THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCU-FILM OPHTHALMIC LIGHT COVER KYT MEDTRONIC OPHTHALMICS: A DIVISION OF MEDTRONIC XOMED, INC. H1302306712 32310500

    Patients

    Seq Age Sex Outcome Treatment
    1 *