BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3385700 · Received September 11, 2013

    Report

    Report Number
    2530154-2013-00008
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 9, 2013
    Report Date
    September 10, 2013
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: LOT HISTORY RECORDS REVIEWED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER, INCLUDING TYPE OF SURGICAL PROCEDURE, METHOD OF IMPLANTATION, PRESENCE OF BACTERIAL CONTAMINATION AND THE OUTCOME FROM THE REVISION SURGERY. RESULTS: NO DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW THAT WOULD BE EXPECT TO CAUSE OR CONTRIBUTE TO PRODUCT DISINTEGRATION AFTER IMPLANTATION. CONCLUSION: AS OF THE DATE OF THE INITIAL REPORT, NO CONCLUSION CAN BE MADE REGARDING THE DISINTEGRATION OF THE MESH. IF ADDITIONAL CLINICAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH XCM BIOLOGIC FOR AN UNK ABDOMINAL SURGERY. FOUR (4) DAYS LATER DURING REMOVAL OF THE WOUND V.A.C. AND WHITE SPONGES, THE XCM BIOLOGIC WAS FOUND TO HAVE DISSOLVED THROUGHOUT THE ABDOMINAL CAVITY. IT WAS DESCRIBED TO HAVE TURNED TO A GREENISH MUSHY FILM. THE XCM BIOLOGIC WAS PEELED AWAY FROM THE SOFT TISSUE, REMOVED, AND THE WOUND WAS WASHED OUT. THE SURGEON PLACED A PROLENE MESH OVER THE WOUND AND CLOSED THE ABDOMINAL TISSUE. THE OUTCOME FOLLOWING SURGERY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455534 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM DSM BIOMEDICAL 30010-32 A8510

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention WOUND V.A.C.