BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOIGIC TISSUE MATRIX

    MDR report key: 2160462 · Received July 5, 2011

    Report

    Report Number
    2530154-2011-00007
    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: ADD'L CLINICAL INFO HAS BEEN REQUESTED. IF ADD'L INFO IS PROVIDED, THE NEW INFO WILL BE SUBMITTED IN A F/U MDR ALONG WITH THE INVESTIGATION OF THE MFG RECORDS. ADD'L LOT# KN89197.

    Description of Event or Problem · 1

    THE PT HAD COSMETIC BREAST SURGERY WITH IMPLANTATION OF XCM BIOLOGIC USED AS A 'DERMAL SLING.' XCM BIOLOGIC WAS SUTURED FROM THE INFRAMAMMARY FOLD TO THE PECTORALIS MAJOR. THE POCKET WAS IRRIGATED WITH BACITRACIN. AT APPROX 6 WEEKS POST-OPERATIVE, THE PT 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 WAS PERFORMED.THE OUTCOME OF THE RE-OPERATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOIGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. KN89274

    Patients

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