BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MVE 25GA PACK WITH CUTTER

    MDR report key: 2017254 · Received March 9, 2011

    Report

    Report Number
    1920664-2011-00005
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 7, 2011
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQE
    PMA / PMN Number
    K980488
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION RESULTS ARE PENDING. (B)(4) - PATIENT OUTCOME WILL BE SUPPLIED WHEN IT IS PROVIDED BY THE REPORT SOURCE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT INSTRUMENTS COULD NOT PASS THROUGH THE CANNULA. WHEN ATTEMPTING TO REINTRODUCE A NEEDLE, THE CANNULA SHEARED OFF. THE PHYSICIAN REMOVED THE CANNULA PIECE WITH A FOREIGN BODY FORCEPS THROUGH AN ENLARGED INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVE 25GA PACK WITH CUTTER HQE BAUSCH & LOMB, INC. CX6925

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention