BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GS COMBINATION PACK W V&AFI&WF

    MDR report key: 3963722 · Received June 19, 2014

    Report

    Report Number
    1920664-2014-00088
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2, SEE 1920664-2014-00087.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER KEPT FREEZING UP AND THERE WAS A HISSING SOUND WHEN THE CUTTER WAS IN USE. THEY USED THE CUTTER ON ANOTHER UNIT AND THE SAME SYRINGE OCCURRED. A NEW PACK WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359172 STELLARIS 25GS COMBINATION PACK W V&AFI&WF HQC BAUSCH & LOMB, INC. V2498

    Patients

    Seq Age Sex Outcome Treatment
    1