BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA COMBINATION PK W AFI AND WF 6/BX

    MDR report key: 4905173 · Received July 8, 2015

    Report

    Report Number
    1920664-2015-00096
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    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 JAPAN REPORTED THE CUTTER DID NOT MOVE SMOOTHLY. THE CUTTER WAS REPLACED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444084 STELLARIS 25GA COMBINATION PK W AFI AND WF 6/BX 25GA COMBINATION PACK HQC BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1