BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3733602 · Received March 24, 2014

    Report

    Report Number
    2530154-2014-00002
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, VERY LITTLE INFO HAS BEEN PROVIDED ABOUT THE IMPLANTATION PROCEDURE, THE REVISION PROCEDURE AND THE PT'S OUTCOME, THE COMPLAINT INVESTIGATION IS THEREFORE LIMITED TO DEVICE HISTORY RECORD REVIEW AND REVIEW OF THE PROVIDED CLINICAL INFO. THE LOT HISTORY RECORD REVIEW SHOWS THAT THE PRODUCT MET ALL PREDETERMINED ACCEPTANCE CRITERIA. THE AVAILABLE CLINICAL INFO DESCRIBES THE PRESENCE OF CONTAMINATION IN THE SURGICAL FIELD, WHICH IS A KNOWN RISK FACTOR FOR DISINTEGRATION OF A BIOLOGIC MESH OR INFECTION OF A SYNTHETIC MESH. 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

    XCM BIOLOGIC WAS IMPLANTED IN THIS PT AS PART OF AN UNK ABDOMINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGICAL FIELD MAY HAVE BEEN CONTAMINATED. APPROXIMATELY 12 DAYS POST-OPERATIVE, IT WAS REPORTED THAT THE MESH BEGAN TO DISINTEGRATE. DURING A SUBSEQUENT REVISION SURGERY, THE REMAINING XCM BIOLOGIC MESH WAS EXPLANTED AND ANOTHER BIOLOGIC MESH WAS IMPLANTED. NO OUTCOME INFO IS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172957 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LG. ABDOM FTM DSM BIOMEDICAL 30010-32 A9686

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R STEROIDS