BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITLENG

    MDR report key: 12092072 · Received June 30, 2021

    Report

    Report Number
    12092072
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 7, 2021
    Manufacturer
    FCI OPHTHALMIC
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INFERIOR PUNCTA WAS DILATED WITH THE SHARP DILATOR. THE FCI GUIDE WAS THEN PASSED THROUGH THE LOWER SYSTEM, WHILE TURNING THE GUIDE IT WAS NOTICED THAT IT DIDN'T GO DOWN, THE GUIDER WAS THEN WITHDRAWN, AND IT WAS NOTICED THAT THE TIP WAS BROKEN OFF. THE TIP WAS STILL IN THE LACRIMAL SYSTEM. X-RAY WAS THEN PERFORMED. IT CONFIRMED THAT THE TIP WAS STILL IN THE LACRIMAL DUCT SYSTEM. PHONE CONSULT WAS PERFORMED WITH DR. WHO RECOMMENDED REMOVAL OF THE FOREIGN BODY. DISCUSSED EVENTS AND PLAN WITH PARENT. ARRANGED FOR REMOVAL TODAY. THE PATIENT WAS AWAKENED IN THE OPERATING ROOM AND TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991964 RITLENG LACRIMAL STENTS AND INTUBATION SETS OKS FCI OPHTHALMIC S1-1460

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA