BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45 DEGREES KELMAN 0.9 MM

    MDR report key: 2540887 · Received April 21, 2010

    Report

    Report Number
    2540887
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 12, 2010
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOURTH PT IN TWO WEEKS TO DEVELOP DESCEMET'S MEMBRANE DETACHMENT WITH COMMON DENOMINATOR BEING THE SAME TYPE OF PHACO TIP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45 DEGREES KELMAN 0.9 MM TURBOSONIC MINI-FLAXED ABS TIP HQC ALCON LABORATORIES 799310 M

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO