BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 1295852 · Received January 22, 2009

    Report

    Report Number
    2031959-2009-00001
    Event Type
    Other
    Date Received
    January 22, 2009
    Date of Event
    October 1, 2008
    Report Date
    January 20, 2009
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE REPORTED EVENTS WE CAN CONCLUDE THAT THE FIRST INFECTION WAS SEEN AFTER ALMOST 3.5 YRS POST IMPLANTATION. THE PT RESPONDED WELL TO THE ANTIBIOTIC TREATMENT WITH POSTERIOR IRRIGATION ON ONE SIDE BUT THE SECOND SIDE REQUIRED SURGERY FOR REMOVAL OF THE PLUG. LATER ON, SIMPLE USE OF ANTIBIOTIC AND IRRIGATION REMOVED THE SECOND PLUG. THE DIFFICULTY IN PLUG REMOVAL BY IRRIGATION COULD HAVE BEEN DUE TO NOT ALLOWING ENOUGH TIME FOR THE ANTIBIOTIC TO ACT ON THE INFECTION AS SEEN WITH THE REMOVAL OF THE SECOND PLUG WHERE SURGERY WAS NOT REQUIRED. AS OF TODAY, THE SMARTPLUGS HAVE BEEN REMOVED AND NO LONGER PRESENT A RISK TO THE PT. THIS CASE IS CLOSED AND NO ADDITIONAL INFO CAN BE EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2003, SMARTPLUG WAS INSERTED INTO BILATERAL LOWER PUNCTA OF A NOW (B)(6) FEMALE PT. THERE IS A HISTORY OF PRIOR HEADED SILICONE PLUG USE, AND THEY WERE REPORTED TO HAVE FALLEN OUT. ON (B)(6) 2006, DISCHARGE FROM THE RL PUNCTA WAS NOTED AND DACRYOCYSTITIS WAS DIAGNOSED. KEFLEX 250MG P.O QID #60 WAS PRESCRIBED. ON (B)(6) 2006, WHAT IS DESCRIBED AS DRAINAGE AND IRRIGATION (D&I) WAS PERFORMED AND THE OS (LL) CLEARED AND THE OD (RL) WAS BLOCKED. ON (B)(6) 2006, DACRYOCYSTORHINOSTOMY SURGERY (RL) WAS PERFORMED. ON (B)(6) 2007 D&I OD (RL) WAS DESCRIBED AS OPEN AND OS (LL) WAS DESCRIBED AS BLOCKED. KEFLEX 500MG QID X2 WEEKS WAS PRESCRIBED. ON (B)(6) 2008, DISCHARGE WAS NOTED FROM LL PUNCTA AND WAS TREATED WITH MAXITROL GTTS. ON (B)(6) 2008, RL PUNCTA WAS BLOCKED AND D&I CLEARED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. 500 35596

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R