BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPEREAGLE PUNCTUM PLUG

    MDR report key: 677296 · Received February 17, 2006

    Report

    Report Number
    1034718-2006-00006
    Event Type
    Other
    Date Received
    February 17, 2006
    Date of Event
    January 18, 2006
    Report Date
    February 17, 2006
    Manufacturer
    EAGLE VISION, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED RECEIVED ON 01/18/2006 OF PATIENT EXPERIENCING AN "ALLERGIC REACTION" OF RIGHT UPPER AND LEFT UPPER PUNCTA AFTER IMPLANTATION IN 2005, OF SUPER EAGLE PUNCTUM PLUGS. NO EXACT DATE OF PLUG REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPEREAGLE PUNCTUM PLUG PUNCTUM PLUG LZU EAGLE VISION, INC. 3131 72888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other