BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 3040536 · Received March 14, 2013

    Report

    Report Number
    2031959-2013-00001
    Event Type
    Other
    Date Received
    March 14, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    PMA / PMN Number
    K022043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REPORTED EVENTS WE CAN CONCLUDE THAT THE SMARTPLUGS WERE IMPLANTED AT LEAST 3 YEARS PRIOR TO THE EVENT (BASED ON THE EXPIRATION DATE OF THE PRODUCT). THE PYOGENIC GRANULOMA WAS REMOVED AND PRODUCT WAS IRRIGATED OUT. THE PT WAS TREATED WITH MAXITROL (OINTMENT AND SOLUTION) AND THE PT IS DOING WELL WITH NO COMPLAINTS. SINCE THE PRODUCT WAS REMOVED WE DO NOT EXPECT ANY FURTHER PROBLEMS WITH THE PT. THIS CASE IS CLOSED AND NO ADDITIONAL INFORMATION CAN BE EXPECTED.

    Description of Event or Problem · 1

    A LARGE SIZE PYOGENIC GRANULOMA LEFT LOWER LID INVOLVING CANALICULUS AND PUNCTA. PURULENT MATERIAL EXPRESSED WITH PRESSURE ON RIGHT LOWER LID AND CANALICULUS. S/P EXC OF PYOGENIC GRANULOMA LEFT LOWER LID. S/P IRRIGATION OF NASOLACRIMAL SYSTEM RIGHT LOWER LID AND LEFT LOWER LID. PT PLACED ON MAXITROL OINTMENT TO LEFT LOWER LID/PUNCTA EVERY 2 HOURS. MAXITROL SOLUTION FOUR TIMES A DAY RIGHT LOWER LID. PT NOW DOING WELL WITH NO COMPLAINTS. PHOTOGRAPHS AVAILABLE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108134 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. 500 073N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention