BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3733604 · Received March 24, 2014

    Report

    Report Number
    2530154-2014-00003
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT UNDERWENT AN UNK SURGICAL PROCEDURE IN LATE 2013 WITH XCM BIOLOGIC MESH IMPLANTATION. APPROX 3 MONTHS LATER, THE PT UNDERWENT AN UNK PROCEDURE AND THE MESH WAS REMOVED, POSSIBLY DUE TO DISINTEGRATION. NO OTHER CLINICAL INFO IS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172905 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, PLASTIC R FTM DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R