BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRATED XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 1920117 · Received December 7, 2010

    Report

    Report Number
    2530154-2010-00003
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE PART NUMBER AND LOT NUMBER OF THE XCM BIOLOGIC SURGICAL MESH USED IN THE PROCEDURE ARE NOT AVAILABLE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ABOUT THE DEVICE AND THE PATIENT ARE ONGOING.

    Description of Event or Problem · 1

    A XCM BIOLOGIC SURGICAL MESH WAS IMPLANTED DURING A NIPPLE AREOLA RECONSTRUCTION PROCEDURE. AT SOME POINT POST-OPERATIVELY, THE PATIENT'S BREAST BECAME SWOLLEN AND RED. IT IS UNKNOWN WHETHER THESE SYMPTOMS WERE DUE TO ALLERGIC REACTION OR INFECTION. THE XCM BIOLOGIC SURGICAL MESH WAS SUBSEQUENTLY REMOVED. THE OUTCOME IS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention