BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPEREAGLE PUNCTUM PLUG

    MDR report key: 3843617 · Received May 23, 2014

    Report

    Report Number
    1034718-2014-00004
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    EAGLE VISION, INC.
    Product Code
    LZU
    PMA / PMN Number
    991130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS FOR ADDITIONAL PATIENT AND PRODUCT INFO HAVE BEEN SUBMITTED. IF ADDITIONAL INFO IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A GRANULOMA AROUND THE PUNCTUM PLUG THAT CAUSED IT TO EXTRUDE ONTO THE LOWER LID OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309058 SUPEREAGLE PUNCTUM PLUG PUNCTUM PLUG LZU EAGLE VISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention