BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELLANSERT TEMPORARY PUNCTUM PLUG

    MDR report key: 3788297 · Received April 29, 2014

    Report

    Report Number
    1034718-2014-00001
    Event Type
    Injury
    Date Received
    April 29, 2014
    Report Date
    April 24, 2014
    Manufacturer
    EAGLE VISION, INC.
    Product Code
    LZU
    PMA / PMN Number
    K053333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE FORCEPS USED FOR INSERTING THE GELLANSERT PLUGS WERE CLEANED WITH ALCOHOL WIPES. THIS IS THE 1ST OF 3 REPORTS FROM THE SAME REPORTER ON THE PRODUCT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT GELLANSERT TEMPORARY PUNCTUM PLUGS WERE USED ON A PRK PT POST SURGERY. THE PLUGS WERE PLACED IN THE PT TO INCREASE THE RETENTION OF OCULAR MEDICATION. THE PT HAS HAD PERSISTENT CANALICULITIS OS. PT HAS HAD IRRIGATION OF THE CANALICULUS, BUT HAS HAD NO RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255874 GELLANSERT TEMPORARY PUNCTUM PLUG PUNCTUM PLUG LZU EAGLE VISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention