BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR VPATCH

    MDR report key: 2963671 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00208
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    September 29, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ATRIUM FOR EVALUATION. THE LOT HISTORY AND STERILIZATION RECORDS OF THIS LOT WERE REVIEWED AND NO DEVIATIONS WERE FOUND. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF FACTORS. INFECTION RATES AFTER OPEN REPAIR OF VENTRAL/INCISIONAL HERNIAS HAVE BEEN REPORTED TO BE AS HIGH AS 20%.

    Description of Event or Problem · 1

    POSTOPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420 C-QUR VPATCH FTL ATRIUM MEDICAL CORP. 31228 10642108

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention