BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3824471 · Received May 7, 2014

    Report

    Report Number
    2530154-2014-00004
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS OF THE DATE OF THIS REPORT, NO PATIENT INFORMATION, NO IMPLANTATION SURGERY INFORMATION OR OUTCOME INFORMATION HAS BEEN PROVIDED. THE AVAILABLE INFORMATION IS INSUFFICIENT TO EVALUATE THIS COMPLAINT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION. IF ADDITIONAL CLINICAL INFORMATION IS PROVIDED, IT WILL BE REPORTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD XCM BIOLOGIC IMPLANTED AS PART OF AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE. APPROXIMATELY 3 TO 4 MONTHS POST-OPERATIVE, THE PATIENT RETURNED WITH SINUS TRACKS AND BUDGES. ALTHOUGH REQUESTED, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION ABOUT THE PATIENT, THE INITIAL SURGERY OR ANY REMEDIAL ACTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274920 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LG ABD WAL FTM DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R