BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W FF

    MDR report key: 3030772 · Received March 27, 2013

    Report

    Report Number
    1920664-2013-00041
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE STERILIZATION AND LOT HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE DRIVE AIR TUBING OF VITREOUS CUTTER CAME OFF DURING THE PROCEDURE. THE SURGEON REPLACED IT WITH ANOTHER AND COMPLETED THE SURGERY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125270 STELLARIS 25GA POSTERIOR PACK W FF HQC BAUSCH & LOMB, INC. BL5325 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1