BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRICATH

    MDR report key: 1002060 · Received February 20, 2008

    Report

    Report Number
    MW5005629
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 20, 2008
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A BALLOON DACRYOPLASTY WITH PLACEMENT OF MINI-MONO-KA TUBE A 3MM BALLOON WAS PASSED THROUGH THE LACRIMAL DUCT AND INFLATED X2. UPON WITHDRAW OF THE BALLOON, THERE WAS SOME RESISTANCE AND WHEN IT CAME OUT, THE BALLOON HAD BEEN RUPTURED. THERE WAS QUESTIONABLY A PIECE OF THE BALLOON WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACRICATH LACRIMAL DUCT CATHETER HNW QUEST MEDICAL, INC. 29565 Z09

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR