BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPECTION RGA 0629 SMARTPLUG

    MDR report key: 628268 · Received August 16, 2005

    Report

    Report Number
    2031959-2005-00004
    Event Type
    Other
    Date Received
    August 16, 2005
    Date of Event
    January 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

    IN 10/03 PT WAS DIAGNOSED WITH KEROTOCONJUNCTIVITIS SICCA, HAD OASIS PLUGS INSERTED, PT COMPLAINED OF CORNEAL DISCOMFORT DUE FEELING THE PLUG. TWO WEEKS LATER PT RETURNED OASIS PLUGS WERE REMOVED AND SMART PLUGS WERE INSERTED. PT COMPLAINED THAT THEIR CONTACTS WERE STILL DRY, EVEN WITH THE PUNCTAL OCCLUSION AND BEGAN RESTASIS IN 07/2004. BY 2005 THE PT COMPLAINED OF PAIN AND SWELLING NEAR THE LEFT LOWER PUNCTA. PALPATION PRODUCTED A PURULENT DISCHARGE AND WHAT WAS THOUGHT TO BE PART OF SMARTPLUG. PT WAS STARTED ON ORAL AND TOPICAL ANTIBIOTIC. PT WAS REFERRED TO OCULAR PLASTIC SURGEON FOR PROBING AND IRRIGATION TO REMOVE THE SMART PLUG. THIS PROCEDURE WAS SUCCESSFUL, BUT LEFT THE PT WITH BRUSING AROUND THE EYES AND A BLOODY DISCHARGE FROM THEIR NOSE FOR ABOUT A WEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R