BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-QUR V PATCH (6.4 CM CIRCLE)

    MDR report key: 2492392 · Received March 13, 2012

    Report

    Report Number
    1219977-2012-00005
    Event Type
    Other
    Date Received
    March 13, 2012
    Date of Event
    January 5, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED. THE DEVICE MET SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THE LIMITED INFORMATION RECEIVED AND NO RETURN OF THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6), PT PRESENTED FOR POST OP FOLLOW-UP WITH CARE OF SWELLING, REDNESS, DRAINAGE AND SPONTANEOUS DRAINAGE OF SEROUS FLUID. ON (B)(6), PT PRESENTED FOR FOLLOW-UP WITH CARE OF SCANT AMOUNT OF SEROSANGUINEOUS DRAINAGE. ON (B)(6), SURGEON REPORTED RECOMMENDED POSSIBLE REMOVAL OF MESH REPLACEMENT WITH STRATTICE BIOLOGICAL GRAFT. ON (B)(6), PT PRESENTED TO (B)(6) EMERGENCY ROOM, WAS ADMITTED, AND REMOVAL OF MESH PERFORMED. OP REPORT PENDING. ON (B)(6) 2012 LABORATORY RESULTS - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-QUR V PATCH (6.4 CM CIRCLE) FTL ATRIUM MEDICAL CORP 31201 10726792

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization