BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL SHIELD

    MDR report key: 617701 · Received June 15, 2005

    Report

    Report Number
    617701
    Event Type
    Injury
    Date Received
    June 15, 2005
    Date of Event
    May 9, 2005
    Report Date
    June 10, 2005
    Manufacturer
    OCULAR PROSTHETICS INC.
    Product Code
    MOE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ORANGE TRANSPARENT CORNEAL PROTECTOR WAS PLACED ON THE PATIENT'S EYE. THE PATIENT UNDERWENT AN ANTERIOR ORBITOTOMY FOR EXCISION OF RIGHT ORBITAL TUMOR WITHOUT COMPLICATIONS. TWO POST-OP VISITS LATER, THE CORNEAL PROTECTOR WAS DISCOVERED AND REMOVED. THE PATIENT'S EYESITE IS ALMOST BASED, RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SHIELD CORNEAL PROTECTOR MOE OCULAR PROSTHETICS INC. AMBER COLOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other| R