BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 23GA POSTERIOR PACK WITH FF 6/BX

    MDR report key: 2770272 · Received October 1, 2012

    Report

    Report Number
    1920664-2012-00190
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE PRODUCT HAS BEEN RETURNED AND EVALUATED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(4) REPORTED THE PNEUMATIC TUBING OF THE VITRECTOMY PACK EJECTED WHILE OPERATING. NO OTHER INFO PROVIDED. ADD'L INFO: THERE WAS NO PT IMPACT, OR MEDICAL INTERVENTION; BUT THERE WAS A DELAY IN SURGERY DUE TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS 23GA POSTERIOR PACK WITH FF 6/BX HQC BAUSCH & LOMB, INC. BL5223 U7901

    Patients

    Seq Age Sex Outcome Treatment
    1