BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELF THREADING MONOKA

    MDR report key: 829541 · Received March 15, 2007

    Report

    Report Number
    MW1042278
    Event Type
    Other
    Date Received
    March 15, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 15, 2007
    Manufacturer
    FCI OPHTHALMICS
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SCHEDULED PROCEDURE A PIECE OF LACRIMAL DUCT INSTRUMENT BROKE OFF IN LACRIMAL STENT AND LODGED IN NASAL LACRIMAL DUCT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF THREADING MONOKA LACRIMAL DUCT PROBE HMX FCI OPHTHALMICS S1-1460U *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Other