BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI

    MDR report key: 2250606 · Received September 2, 2011

    Report

    Report Number
    2250606
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ALCON
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOOTSWITCH FOR THE INFINITI CATARACT MACHINE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI CATARACT EXTRACTION DEVICE HQC ALCON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *