BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 2152505 · Received June 22, 2011

    Report

    Report Number
    1920664-2011-00069
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM SINGAPORE STATES: "VITRECTOMY CUTTER IS UNABLE TO CUT EFFICIENTLY. FOUND TUBING FOR PNEUMATIC LOOSE, REATTACHED AND CAME LOOSE AGAIN. SCRUB NURSE PROCEEDED TO TAPE UP TUBING. PATIENT OUTCOME: RECOVERED. AFFECTED EYE: RIGHT" ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQC BAUSCH & LOMB U04910

    Patients

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