BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM 23 GA PROCEDURAL PACKS

    MDR report key: 2191050 · Received July 19, 2011

    Report

    Report Number
    1920664-2011-00095
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQE
    PMA / PMN Number
    K020911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT IS UNKNOWN IF IT WILL BE RETURNED. REPORT 1 OF 3.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM FRANCE STATES: "VITRECTOMY DOESN'S CUT AND LOW ASPIRATION. NO PATIENT IMPACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM 23 GA PROCEDURAL PACKS HQC HQE BAUSCH & LOMB U4790

    Patients

    Seq Age Sex Outcome Treatment
    1 MILLENNIUM EQUIPMENT (BAUSCH + LOMB)