BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR TACSHIELD

    MDR report key: 2963722 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00198
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    November 15, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ATRIUM FOR EVAL. DUE TO LIMITED INFO - A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. CAUSE OF EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    POST OPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439 C-QUR TACSHIELD FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention