BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUE MESH

    MDR report key: 4107010 · Received September 11, 2014

    Report

    Report Number
    1219977-2014-00303
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE F/U REPORT ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    PT EXPERIENCED SEROMA AND CHRONIC PAIN. MESH WAS NOT INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562913 C-QUE MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention PERMANENT SUTURES