BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPLUG

    MDR report key: 840830 · Received April 20, 2007

    Report

    Report Number
    2031959-2007-00002
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    November 2, 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

    Additional Manufacturer Narrative · 1

    IN 2007, PT. RETURNED AND IT WAS MUCH BETTER. THE OS WAS A LITTLE SORE AND THERE WAS TEAR POOLING. THE PT. WAS ADVISED TO DISCONTINUE THE TOBRADEX AND START RESTASIS BID OU AND RETURN IN 6 WEEKS. SMARTPLUG HAS BEEN IRRIGATED AND INFECTION HAS DISAPPEARED. SMARTPLUG NO LONGER POSES A RISK TO THE PT. CASE IS CLOSED. NO ADD'L INFO CAN BE EXPECTED.

    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 FEMALE IN 2006. (LOWER PUNCTA). IN 2007, PT PRESENTED WITH OS NLD PLUGGED WITH GRANULATED TISSUE AT PUNCTA AND INFECTION. PT WAS TREATED WITH TOBRADEX TID OU AND KEFELX 250MG. PO QID AND TOLD TO RETURN IN ONE WEEK. SIX DAYS LATER, OS BETTER, BUT NOW OD PLUGGED. CONTINUE KEFLEX AND TOBRADEX. SEVEN DAYS LATER, ONLY SLIGHT IMPROVEMENT SEEN. PUNCTA DILATED AND IRRIGATED. JPT TO DISCONTINUE KEFLEX AND CONTINUE TOBRADEX BID FOR 2 WEEKS. THE FOLLOWING NINETEEN DAYS, NLD ABSESS, PUNCTA LOOKED CLOSED. RESTART KEFLEX TID OU AND TOBRADEX TID OU. TREATED WITH VIGAMOX QID, OU. THE NEXT MONTH, STILL INFECTED, NLD IRRIGATIONS PERFORMED. PLUG SEEN TO COME OUT LL PUNCTA (WHEN UPPER IRRIGATED) AND NOT SURE ABOUT OD. THE PT. WAS TO DISCONTINUE THE KEFLEX AND TOBRADEX GTTS. START TOBRADEX OINTMENT QHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. MODEL 500 46959

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R