BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2160461 · Received July 5, 2011

    Report

    Report Number
    2530154-2011-00006
    Event Type
    Injury
    Date Received
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PART AND LOT NUMBERS WERE NOT PROVIDED AS OF THE DATE OF THIS REPORT. THIS INFORMATION AS WELL AS ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS PROVIDED, THE NEW INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE PATIENT HAD BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF XCM BIOLOGIC AS 'DERMAL SLING.' XCM BIOLOGIC WAS SUTURED FROM THE INFRAMAMMARY FOLD TO THE PECTORALIS MAJOR. THE POCKET WAS IRRIGATED WITH BACITRACIN AND A BREAST IMPLANT WAS IMPLANTED. AT APPROXIMATELY 6 WEEKS POST-OPERATIVE, THE PATIENT PRESENTED WITH ERYTHEMA OVER THE AREA OF XCM BIOLOGIC IMPLANTATION. RE-OPERATION REVEALED PURULENCE AND INTACT BUT DISSOLVING XCM BIOLOGIC MESH. MICROBIAL CULTURES WERE NEGATIVE. WASHOUT OF THE POCKET WAS PERFORMED AND THE BREAST IMPLANT WAS EXCHANGED. THE OUTCOME OF THE RE-OPERATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BREAST IMPLANT| BACITRACIN