BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPLUG

    MDR report key: 3929774 · Received June 25, 2014

    Report

    Report Number
    2031959-2014-00001
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    January 1, 2013
    Report Date
    June 24, 2014
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    PMA / PMN Number
    K022043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REPORTED EVENTS WE CAN CONCLUDE THAT THE SMARTPLUGS WERE IMPLANTED AT LEAST ONE YEAR PRIOR TO THE DIAGNOSIS OF CANALICULITIS IN LEFT UPPER LID AND EPHIPHORA ON LEFT EYE. IT WAS AFTER TWO YEARS THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES TO HAVE THE PLUGS REMOVED. AS REPORTED IN THE LITERATURE SOME SURGEONS FIRST CHOICE OF TREATMENT IS SURGICAL REMOVAL WHILE OTHERS TREAT THE INFECTIONS AND ONLY THEN WHEN THE SWELLING IS DOWN THEY REMOVE THE PLUG BY IRRIGATION OR MASSAGING. FROM THE REPORT ALL WE CAN CONCLUDE IS THAT THE PLUGS HAVE BEEN REMOVED AND NO LONGER PRESENT A POTENTIAL RISK OF SECONDARY INFECTION TO THE PT. THE CASE IS CLOSED AND NO ADDITIONAL INFO CAN BE EXPECTED.

    Description of Event or Problem · 1

    REFER TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369822 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. 500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention