BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELLANSERT TEMPORARY PUNCTUM PLUG

    MDR report key: 3788309 · Received April 29, 2014

    Report

    Report Number
    1034718-2014-00003
    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 3RD 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 IS ON A COURSE OF ANTIBIOTICS (DOXYCYCLINE) TO SEE IF SYMPTOMS IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255748 GELLANSERT TEMPORARY PUNCTUM PLUG PUNCTUM PLUG LZU EAGLE VISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention