BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 4132089 · Received September 26, 2014

    Report

    Report Number
    2530154-2014-00007
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 26, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DEVICE AND CLINICAL INFO. HOWEVER, AS OF THE DATE OF THIS REPORT, NO INVESTIGATION COULD BE COMPLETED SINCE THE DEVICE PART AND LOT NUMBER INFO HAS NOT BEEN PROVIDED. IF THE REQUESTED INFO 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 FOR AN UNK ABDOMINAL SURGICAL PROCEDURE. APPROX THREE MONTHS LATER, THE PT PRESENTED WITH RE-HERNIATION. DURING REVISION SURGERY, A TEAR WAS IDENTIFIED IN THE MIDDLE OF THE XCM BIOLOGIC. THE TORN PART OF THE XCM BIOLOGIC WAS REMOVED AND A NEW XCM BIOLOGIC WAS IMPLANTED. THE PT WAS REPORTED AS DOING FINE AFTER THE RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600421 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LG ABD WAL FTM DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention