BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAGLE PLUG1

    MDR report key: 2870145 · Received December 3, 2012

    Report

    Report Number
    1034718-2012-00003
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 6, 2012
    Manufacturer
    EAGLE VISION, INC.
    Product Code
    LZU
    PMA / PMN Number
    K991130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PUNCTUM PLUG WAS PLACED IN PATIENT FOR TREATMENT OF DRY EYE ON (B)(6) 2012. PUNCTUM PLUG WAS REMOVED ON (B)(6) 2012, REPORTEDLY DUE TO PYROGENIC GRANULOMA. PATIENT TREATED WITH TOBRADEX 4X/DAY FOR 1 WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE PLUG1 PUNCTUM PLUG LZU EAGLE VISION, INC. 77120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention