BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR VPATCH

    MDR report key: 2963703 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00200
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    May 25, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MESH WAS BEING RETURNED DUE TO A SUSPECTED INFECTION. CONVERSATIONS WITH THE SURGEON THE DAY OF THE EXPLANT INDICATED THAT BACTERIAL CULTURE SWABS OF THE AREA DID NOT COME BACK POSITIVE FOR INFECTION. ATRIUM ENGINEERING AND MARKETING PERSONNEL AT THE SITE NOTED THAT THE PT'S SKIN WAS RED AROUND THE AREA OF MESH IMPLANTATION AND THAT THERE WERE NOT NOTICEABLE SIGNS OF INFECTION SUCH AS SINUS TRACTS, OPEN WOUNDS OR PUSS. HOWEVER, SINCE THE PT WAS STILL EXPERIENCING SOME ERYTHEMA AND PAIN AROUND THE SIGHT OF IMPLANTATION THE MESH WAS EXPLANTED. THERE WAS NO EVIDENCE TO SUBSTANTIATE THE PRESENCE OF A MESH RELATED INFECTION, AND THE IMPLANT DEMONSTRATED VERY GOOD TISSUE INCORPORATION AND HEALING. THERE ARE MANY POTENTIAL CAUSES OF SKIN IRRITATION IN SURGICAL PTS WHICH COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION OBSERVED IN THIS PT. THE LOT NUMBER OF THIS MESH EXPLANT WAS NOT PROVIDED WITH THIS RGA; THEREFORE, NO REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED. BASED UPON THE LIMITED INFORMATION PROVIDED IN THE RGA, AND THE EXAMINATION OF THE EXPLANT RETURNED, THERE ARE NOT REASONS TO CONCLUDE THAT THIS C-QUR V-PATCH MESH DEVICE ITSELF WAS THE ROOT CAUSE OF THE ERYTHEMA AND PAIN DESCRIBED IN THIS CASE.

    Description of Event or Problem · 1

    PT HAD PRONOUNCED ERYTHEMA AND PAIN RIGHT AFTER SURGERY WHEN A C-QUR V-PATCH WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431 C-QUR VPATCH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention