BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE VENT MILLENNIUM SYSTEM

    MDR report key: 2152503 · Received June 22, 2011

    Report

    Report Number
    1920664-2011-00074
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQE
    PMA / PMN Number
    K961310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING "SURGEON REPORTED AN ASPIRATION SURGE DURING OPERATION AND POSSIBLE FOOT CONTROL FAILURE. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE VENT MILLENNIUM SYSTEM HQE BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1