BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 4562141 · Received February 11, 2015

    Report

    Report Number
    4562141
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 11, 2015
    Manufacturer
    FCI OPHTHALMICS, INC.
    Product Code
    OKS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT WAS ADMITTED WITH TRAUMA TO THE LACRIMAL (TEAR) DUCT. DURING THE PROCEDURE TO REPAIR IT, THE RITLENG INTRODUCER TIP BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN EYELID LACERATION STENT. X-RAYS AND CT SCAN SHOWED A 5-6 MM PIECE OF METAL NEAR THE LACRIMAL SPACE. THE PATIENT WILL HAVE FOLLOW-UP WITH PEDIATRIC OTOLARYNGOLOGY. PER THE MANUFACTURER, THE TIP IS NOT MRI COMPATIBLE.MANUFACTURER RESPONSE: THE MANUFACTURER CONFIRMED LACK OF MRI COMPATIBILITY. THE DELICATE NATURE OF THE DEVICE CAN RESULT IN UNINTENDED BENDING DURING PACKAGING, PROCESSING OR USE. WE ARE STILL INVESTIGATING PROCESSING AND STORAGE STANDARDS FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102501 * LACRIMAL STENTS AND INTUBATION SETS OKS FCI OPHTHALMICS, INC. FCI S1-1460U *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R