BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PLUG

    MDR report key: 527819 · Received May 11, 2004

    Report

    Report Number
    MW1032078
    Event Type
    Injury
    Date Received
    May 11, 2004
    Date of Event
    December 9, 2003
    Report Date
    May 11, 2004
    Manufacturer
    MEDENNIUM, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SMARTPLUG MANUFACTURED BY MEDENNIUM WAS INSERTED INTO PT'S LOWER CANALICULUS -TEAR- DUCT CAUSING SYMPTOMS OF EPIPHORA -EXCESSIVE TEARING-. THESE PLUGS ARE ADVERTISED TO BE REVERSIBLE AND REMOVABLE BY IRRIGATING THE TEAR DUCT. THE PLUG COULD NOT BE IRRIGATED OUT OF THE TEAR DUCT AND, AS A RESULT, THE PT REQURED SURGICAL REMOVAL OF THE PLUG WITH A DACRYOCYSTORHINOSTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART PLUG * LZU MEDENNIUM, INC. SMARTPLUG *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention