BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4870828 · Received June 24, 2015

    Report

    Report Number
    1920664-2015-00082
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 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

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2, SEE 1920664-2015-00081.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING THE PROCEDURE, THE CUTTER WOULD NOT CUT AN 5000 CPM. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410187 STELLARIS 25GA COMBINATION PK W AFI&WF 6/BX 25GA COMBINATION PACK HQC BAUSCH & LOMB, INC. V3735

    Patients

    Seq Age Sex Outcome Treatment
    1