BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PLUG

    MDR report key: 887542 · Received July 25, 2007

    Report

    Report Number
    MW5003173
    Event Type
    Injury
    Date Received
    July 25, 2007
    Date of Event
    January 25, 2007
    Report Date
    July 19, 2007
    Manufacturer
    MEDENNIUM
    Product Code
    LZU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATES OF USE: 2006. DIAGNOSIS OR REASON FOR USE: DRY EYES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. LOCATION: LOWER LIDS OU. OS NLD PLUGGED WITH GRANULATE TISSUE AT PUNTA AND PRESENTS WITH INFECTION. TOBRADEX QTTS TID, OU AND KEFLEX 250MG PO QID RETURN IN ONE WEEK. IN 2007 - OS BETTER BUT NOW OD PLUGGED. CONTINUE KEFLEX AND TOBRADEX. THE FOLLOWING MONTH - PT CONTINUES WITH ONLY SLIGHT IMPROVEMENT. PUNTA DILATED AND IRRIGATED. DISCONTINUE KEFLEX AND CONTINUE TOBRADEX TID OU. FIVE DAYS LATER - STABLE, CONTINUE TOBRADEX BID FOR 2 WEEKS. TWO WEEKS LATER - NLD ABSCESS, PUNTA LOOKED CLOSED. RESTART KEFLEX TID, OU AND TOBRADEX TID OU. THE FOLLOWING MONTH - STILL INFECTED, NLD IRRIGATIONS PERFORMED. PLUG SEEN TO COME OUT OS AND NOT SURE OD. DISCONTINUE KEFLEX AND TOBRADEX QTTS. START TOBRADEX OINTMENT QHS. PT WILL RETURN TWELVE DAYS LATER. PT WAS SEEN FOR FOLLOW UP THE SAME DAY AND REPORTED MUCH BETTER, OS A LITTLE SORE, AND TEAR POOLING. EXAMINATION REVEALED A CLEAR PUNCTA. PLAN: DISCONTINUE TOBRADEX AND START RESTASIS, O.U. PT WILL RETURN IN 6 WEEKS. DR THE FOLLOWING MONTH AND HAS NOT HEARD BACK AS OF TODAY. PLEASE CHECK WITH HIM REGARDING STATUS OF OUT CASE. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART PLUG SMART PLUG LZU MEDENNIUM 500 46959

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention