BEUDAMED
    FDA Adverse Event Other Summary report: N

    CQUR MESH

    MDR report key: 2593897 · Received May 24, 2012

    Report

    Report Number
    1219977-2012-00011
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    PT WAS TREATED FOR OPEN INCISIONAL HERNIA REPAIR WITH C-QUR MESH. PT RETURNED 1 MONTH LATER. PT HAD RECURRENCE AND THE MESH WAS REMOVED. POSSIBLE INFECTION. SURGEON MENTIONED SHE DID SOME STRETCHING EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CQUR MESH FTL ATRIUM MEDICAL CORP. 31538 10734663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other