BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITRECTOMY CUTTER

    MDR report key: 3902827 · Received February 20, 2014

    Report

    Report Number
    1920664-2014-00020
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 31, 2014
    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

    A LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER DID NOT MOVE, BUT DID NOT ASPIRATE AND PULLED ON THE VITREOUS BODY. THERE WAS NO IMPACT TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106933 STELLARIS 25G VITRECTOMY CUTTER NONE HQC BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1