BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2860544 · Received December 4, 2012

    Report

    Report Number
    2530154-2012-00017
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    KENSEY NASH CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION IS AVAILABLE TO EVALUATE THIS COMPLAINT. ADDITIONAL CLINICAL AND TECHNICAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS PROVIDED, IT WILL BE REPORTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT XCM BIOLOGIC WAS IMPLANTED IN A PT FOR AN UNKNOWN REASON. APPROXIMATELY 4 TO 5 DAYS AFTER IMPLANTATION, THE MESH DISSOLVED. THE REMAINING MESH MATERIAL WAS EXPLANTED AND REPLACED WITH A SYNTHETIC SURGICAL MESH. NO OTHER INFORMATION IS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention