BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2160475 · Received July 5, 2011

    Report

    Report Number
    2530154-2011-00004
    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: ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS PROVIDED, THE NEW INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP MDR ALONG WITH THE INVESTIGATION OF THE MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL 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 5 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. THE XCM BIOLOGIC WAS REMOVED. MICROBIAL CULTURES WERE NEGATIVE. THE BREAST IMPLANTS WERE 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 BIOLOGICAL SURGICAL MESH FTM KENSEY NASH CORP. KN89195

    Patients

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