BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G VIT CUTTER 6/BX

    MDR report key: 2926517 · Received January 17, 2013

    Report

    Report Number
    1920664-2013-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    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 DEVICE HAS NOT BEEN RECEIVED FOR EVAL AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD THE DEVICE BECOME AVAILABLE FOR INVESTIGATION. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(4) REPORTED THE POST OF THE CUTTER DID NOT CLOSE COMPLETELY WHILE CUTTING. ASPIRATION CONTINUED. THERE WAS NO INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25330 STELLARIS 25G VIT CUTTER 6/BX HQC BAUSCH & LOMB, INC. BL5625 U9330

    Patients

    Seq Age Sex Outcome Treatment
    1