BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PLUG

    MDR report key: 2170019 · Received May 24, 2011

    Report

    Report Number
    2031959-2011-00002
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2008
    Report Date
    May 23, 2011
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE MED RECORDS BELONGING TO THE PRIMARY PHYSICIAN, WE OBSERVED THAT SEVERAL IRRIGATION ATTEMPTS WERE PERFORMED IN THE UPPER PUNCTA YIELDING INDICATIONS THAT THE LACRIMAL SYS WAS CLEAR, "FLUID FLOWS FREELY". IN THIS SPECIFIC CASE, THE COMBINATION OF A CAUTERIZATION OF THE LOWER PUNCTA WITH USE OF SILICONE PLUGS IN THE UPPER PUNCTA FOLLOWED BY SMART PLUGS NI THE UPPER PUNCTA FURTHER COMPLICATES THE TRUE CAUSE OF INFECTION AND EPIPHORA. THIS IS THE FIRST CASE WE HAVE ENCOUNTERED OF A COMBINATION PROCEDURE OF A CAUTERIZATION IN THE LOWER PUNCTA AND A SMART PLUG OCCLUSION IN THE UPPER PUNCTA. THIS COMBINATION MAY FURTHER COMPLICATE THE EFFECTIVE IRRIGATION OF SMART PLUGS. THE FACT THAT THERE IS NO MED RECORD INDICATING THAT THE GO PLUG'S (ENGLE VISION) WERE ACTUALLY REMOVED LEAVES THE QUESTION OF WHETHER THEY FELL OUT OR MIGRATED INTO THE PUNCTA. THIS IS FURTHER EVIDENCED BY THE PATHOLOGY REPORT THAT THE REMNANTS OF EXTRACTED MATERIAL WERE TWICE THE SIZE OF A FULLY EXPANDED SMART PLUG AND MORE IN LINE WITH A TYPICAL SILICONE PLUG DIAMETER. REGARDLESS OF WHAT THE PUNCTAL PLUG WAS, THE SURGICAL PROCEDURE HAS RESOLVED THE SITUATION OF EPIPHORA AND INFECTION AND THEY NO LONGER PRESENT A RISK TO THE PT. THIS CASE IS NOW CLOSED AND NO ADD'L INFO CAN BE EXPECTED.

    Description of Event or Problem · 1

    A PT WITH PREVIOUS HISTORY OF RADIAL KERATOTOMY, CORNEAL ULCERS, AND SJOGRENS SYNDROME RECEIVES SMART PLUGS LOT #33328 IN LOWER PUNCTA LLL AND RLL ON (B)(6)-2003. ON (B)(6) 2004, PT SIGNS CONSENT FOR IRRIGATION AND PROBING OF LOWER PUNCTA AND THE PT HAS GO PLUGS (EAGLE VISION SILICONE HEADED PLUGS) INSERTED IN UPPER PUNCTA. ON (B)(6)-2004, PT SIGNS CONSENT FOR CAUTERIZATION OF LOWER PUNCTA. RISKS ARE CLEARLY DEFINED ON FORM. ON (B)(6)-2004, PT RECEIVES SMART PLUGS LOT #40248 IN UPPER PUNCTA. ON (B)(6) 2005, AFTER THE PT REPORTS EPIPHORA, THE DR IRRIGATES AND PROBES THE UPPER PUNCTA AND STATES THAT THE FLUID FLOWS FREELY. ON (B)(6) OF 2008, AN OCULOPLASTIC SURGEON DIAGNOSED PT WITH A SEVERE INFECTION ON THE UPPER PUNCTA AND DETERMINED PLUGS WERE STILL IN THE UPPER PUNCTA. THE DOCTOR PERFORMS A CANALICUOSTOMY TO REMOVE THE UPPER PLUGS, SCAR TISSUE AND RE-CONSTRUCT THE PREVIOUSLY CAUTERIZED LOWER PUNCTA. FOLLOWING THE SURGERY, THE PT HAD IMMEDIATE RELIEF, THE EYES STOPPED TEARING AND SHE NO LONGER SUFFERED FROM INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART PLUG PUNCTAL PLUG LZU MEDENNIUM, INC. 500 141J

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention