BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PLUG

    MDR report key: 3795494 · Received May 2, 2014

    Report

    Report Number
    MW5035940
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    January 23, 2013
    Report Date
    May 1, 2014
    Manufacturer
    MEDENNIUM
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SMARTPLUGS, INTRACANALICULAR PLUGS BY MEDENNIUM, INSTALLED IN MY TEAR DUCT CANALICULIS (ALL 4 - BOTH EYES, UPPER AND LOWER EYELIDS) IN (B)(6) 2011. IN (B)(6) 2012, I WAS DIAGNOSED WITH CANALICULITIS IN LEFT UPPER EYELID AND EPIPHORA IN LEFT EYE. IN (B)(6) 2013, I HAD A SURGERY CANNALICULI REPAIR, AND REMOVED ONE SMART PLUG. IN (B)(6) 2013, I HAD A DACRYOCYSTORHINOSTOMY (DCR) SURGERY ON MY LEFT EYE TEAR DUCT BLOCKED BY MIGRATED SMART PLUG. IN (B)(6) 2013, I WAS DIAGNOSED WITH CANALICULITIS IN MY RIGHT UPPER EYELID, AND I HAD A SURGICAL PROCEDURE DONE - REMOVAL OF FOREIGN BODY FROM CANALICULI - A SMART PLUG WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263770 SMART PLUG SMART PLUG LZU MEDENNIUM
    263771 SMART PLUG SMART PLUG LZU MEDENNIUM
    263772 SMART PLUG SMART PLUG LZU MEDENNIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention