BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION

    MDR report key: 5140018 · Received October 9, 2015

    Report

    Report Number
    5140018
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    February 6, 2013
    Report Date
    October 8, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TUBING IN THE STERILE PACKAGE WAS BROKEN WHEN IT ARRIVED TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671860 FUSION UNIT, PHACOFRAGMENTATION HQC ABBOTT MEDICAL OPTICS INC. (AMO) CK02003

    Patients

    Seq Age Sex Outcome Treatment
    1