BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM PROLOOP MESH

    MDR report key: 2954132 · Received February 7, 2013

    Report

    Report Number
    MW5028893
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 29, 2010
    Report Date
    February 7, 2013
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE EVENTS REGARDING ATRIUM PROLOOP HERNIA MESH. THE PT STATED THAT THE INCISION FROM THE IMPLANTATION OF THE MESH BECAME INFECTED, AND HE HAD TO HAVE IT CLEANED OUT SEVERAL TIMES. ON (B)(6) 2012, THE PT WENT TO HIS DOCTOR TO HAVE THE INFECTION CLEANED OUT, AND THE INCISION REMAINED OPEN FOR TWO MONTHS. HE STATED HE WAS TAKING ANTIBIOTICS TO HELP CLEAR THE INFECTION, BUT THE INCISION NEVER HEALED PROPERLY. PT STATED ON (B)(6) 2012 THE INCISION SEEMED TO BE HEALED, HOWEVER, ON (B)(6) 2012, THE INCISION RUPTURED AGAIN AND WAS STILL INFECTED. THE PT SAYS HE SAW THREE DOCTORS, AND THE THIRD DOCTOR CONFIRMED THE INFECTION WAS CAUSED BY THE MESH. THE THIRD DOCTOR EXPLANTED THE MESH ON (B)(6) 2013. DURING THE THREE YEARS THE MESH WAS IMPLANTED, THE PT EXPERIENCED MULTIPLE INFECTIONS, PAIN, SWELLING, DRAINAGE, AND HARDENING OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51877 ATRIUM PROLOOP MESH HERNIA MESH FTL ATRIUM MEDICAL CORP 10452816

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other