BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR

    MDR report key: 4524395 · Received February 10, 2015

    Report

    Report Number
    MW5040760
    Event Type
    Injury
    Date Received
    February 10, 2015
    Report Date
    February 10, 2015
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    F T
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2011, I HAD AN UMBILICAL HERNIA. IMPLANT OF ATRIUM CQUR MESH. BEGAN FEELING SICK, GOT WORSE. WENT BACK, HAD TO HAVE THE MESH REMOVED ABOUT 0 DAY LATER, DOCTOR NOTICED THE MESH HAD HARDENED AND MASS AROUND THE AREA WHERE MESH HAD BEEN. HAD ANOTHER MESH PUT IN. THREE AND A HALF YEARS LATER, I AM STILL NOT ABLE TO WORK, IN CONSTANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97257 CQUR CQUR MESH F T ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O| R| S