BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 2040276 · Received February 15, 2011

    Report

    Report Number
    1920664-2011-00014
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    P603331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BUBBLES DURING A PROCEDURE. NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQC BAUSCH & LOMB U5406

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSH + LOMB)