BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 3687949 · Received February 28, 2014

    Report

    Report Number
    1219977-2014-00090
    Event Type
    Injury
    Date Received
    February 28, 2014
    Report Date
    February 1, 2012
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO PERFORM A FULL INVESTIGATION AS NO SAMPLE, PRODUCT CODE OR LOT NUMBER WAS AVAILABLE. REVIEW OF COMPLAINTS DOES NOT SHOW ANY SIMILAR REPORTS RELATED TO A DEVICE FAILURE. IF ANY FURTHER DETAILS ARE PROVIDED A FOLLOW UP REPORT WILL BE SUBMITTED. THE OTHER SIX REPORTS ARE: 1219977-2014-00085, 00086, 00087, 00088, 00089 AND 00091.

    Description of Event or Problem · 1

    RECEIVED REPORT OF SEVEN LARGE SEROMAS, SOME ACCOMPANIED BY SKIN REACTIONS, WITH C-QUR. DOCTOR HAS BEEN USING PRODUCT FOR FOUR YEARS. DOCTOR DOES NOT FEEL SEROMA RATE WAS UNUSUAL AS HE HAS DONE OVER 100 CASES WITH C-QUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124440 C-QUR MESH FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention