BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2061780 · Received April 13, 2011

    Report

    Report Number
    MW5020279
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONSTELLATION VISION SYSTEM S/N (B)(4) MALFUNCTIONED (STOPPED WORKING) IN THE MIDDLE OF A CASE. IT WAS REPLACED WITH ANOTHER MACHINE AND CASE PROCEEDED. NO ADVERSE EFFECT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION CONSTELLATION VISION SYSTEM HQC ALCON LABORATORIES CONSTELLATION

    Patients

    Seq Age Sex Outcome Treatment
    1