BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPECTION RGA 0629 SMARTPLUG

    MDR report key: 628343 · Received August 16, 2005

    Report

    Report Number
    2031959-2005-00003
    Event Type
    Other
    Date Received
    August 16, 2005
    Date of Event
    June 10, 2005
    Report Date
    August 15, 2005
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "PATIENT WAS DIAGNOSED WITH KERATOCONJUNCTIVITIS SICCA, HAD OASIS PLUGS INSERTED, WHICH WERE LOST. PATIENT RETURNED WAS FIT WITH LARGER OASIS PLUGS, ALSO LOST. PATIENT RETURNED FOR PUNCTAL OCCLUSION WITH SMARTPLUGS IN 04. THIS WAS FOLLOWED WITHIN TWO MONTHS OF COMPLAINTS OF EXCESSIVE OVERTEARING IN RIGHT EYE ONLY. PATIENT WAS TRETED WITH TROBADEX FOR BLEPHARITIS, TO NO AVAIL. AFTER SEVERAL MONTHS OF DISCOMFORT PATIENT WANTED SMARTPLUG REMOVED IN THE RIGHT EYE BECAUSE OF EXCESSIVE TEARING. ATTEMPTS WERE MADE AT FLUSHING THE PLUG THROUGH THE LACRIMAL DUCT, WITHOUT SUCCESS, USING ROOM TEMPERATURE AND CHILLED SALINE. PATIENT WAS REFERRED TO OCULAR PLASTIC SURGEON FOR REMOVAL OF PLUG, THE SURGEON WAS UNABLE TO FLUSH THE PLUG AND SCHEDULED PATIENT FOR SURGICAL REMOVAL. AFTER CONTACTING MEDENNIUM, THERE WAS A LAST DITCH EFFORT TO REMOVE THE PLUG WITHOUT SURGICAL METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPECTION RGA 0629 SMARTPLUG PUNCTUM PLUG LZU MEDENNIUM, INC. MODEL 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R