BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 840839 · Received April 20, 2007

    Report

    Report Number
    2031959-2007-00003
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    November 27, 2006
    Report Date
    April 19, 2007
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 3-19-07, DOCTOR'S OFFICE CALLED MEDENNIUM TO REPORT THE FOLLOWING: SMART PLUGS WERE INSERTED IN A MALE IN 2004. (LOWER PUNCTA). IN 2006, PT PRESENTED WITH MUCAS AND MARKED CONJUNCTIVITIS. PT WAS TREATED WITH VIGAMOX AND FLAREX TID FOR ONE WEEK. THE NEXT MONTH, THE PT LOOKED MUCH BETTER AND PT WAS INDICATED TO DECREASE VIGAMOX AND FLAREX TO BID, OU FOR ONE MORE WEEK. TWO MONTHS LATER PT FELT INFECTION HAD RETURNED. ON EXAMINATION, IT WAS NOTED THAT THERE WAS PUS IN THE TEAR DUCT. TREATED WITH VIGAMOX QID, OU AND KEFLEX 250MG. QID FOR ONE WEEK. NINETEEN DAYS LATER, LOWER PUNCTA IRRIGATED WITHOUT COMPLICATIONS. STARTED ON RESTASIS AND LID SCRUBS. THE FOLLOWING MONTH,FOLLOW-UP SHOWED ALL CLEAR AND CONTINUED WITH SAME TREATMENT REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. MODEL 500 39773

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R