BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRAWFORD LACRIMAL INTUBATION SET W/O SUTURE

    MDR report key: 2001147 · Received February 16, 2011

    Report

    Report Number
    2001147
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    JEDMED INSTRUMENT COMPANY
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER SERIAL DILITATION OF THE PUNCTA WAS PERFORMED, A CRAWFORD STENT WAS PLACED THROUGH THE INFERIOR SYSTEM INTO THE INFERIOR MEATUS AND BROUGHT OUT WITH A CRAWFORD HOOK. THE STENT BROKE WITHIN THE NASOLACRIMAL DUCT. WE WERE ABLE TO REMOVE THIS FROM THE NASOLACRIMAL DUCT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRAWFORD LACRIMAL INTUBATION SET W/O SUTURE CRAWFORD LACRIMAL INTUBATION SET OKS JEDMED INSTRUMENT COMPANY * A11409

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR