BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS MICRO INCISION VACUUM PK 6/BX

    MDR report key: 3979239 · Received July 17, 2014

    Report

    Report Number
    1920664-2014-00109
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 3, SEE 1920664-2014-00108 AND 1920664-2014-00110.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE TUBING WAS BLOCKED AND REQUIRED THEM TO REPLACE THE PACK TO COMPLETE THE SURGERY. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420512 STELLARIS MICRO INCISION VACUUM PK 6/BX HQC BAUSCH & LOMB, INC. V2520

    Patients

    Seq Age Sex Outcome Treatment
    1