BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VITRECTOMY PACK W AFI&WF

    MDR report key: 3963571 · Received May 30, 2014

    Report

    Report Number
    1920664-2014-00084
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 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

    STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2, SEE 1920664-2014-00083.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THAT THE CUTTER DID NOT CUT. A REPLACEMENT CUTTER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319794 STELLARIS 25G VITRECTOMY PACK W AFI&WF HQC BAUSCH & LOMB, INC. U9650

    Patients

    Seq Age Sex Outcome Treatment
    1