BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3184400 · Received June 17, 2013

    Report

    Report Number
    2530154-2013-00005
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT LOT NUMBER HAS NOT BEEN PROVIDED. THEREFORE, THERE IS INSUFFICIENT INFORMATION TO EVALUATE THE MANUFACTURING RECORDS. NO INFORMATION HAS BEEN PROVIDED ABOUT THE METHOD OF MESH IMPLANTATION, SURGICAL WOUND CLASS, CONCOMITANT SURGICAL PROCEDURES, SUBSEQUENT SURGICAL PROCEDURE(S) OR THE PATIENT'S CLINICAL CONDITION. THIS INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. IF ADDITIONAL INFORMATION IS PROVIDED THAT ALLOWS EVALUATION OF THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: AS OF THE DATE OF THIS INITIAL MDR, NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN OPEN ABDOMEN AND WAS IMPLANTED WITH XCM BIOLOGIC ON AN UNKNOWN DATE. NO OPERATIVE INFORMATION HAS BEEN PROVIDED. AT SOME POINT POST-OPERATIVE, THE PATIENT DEVELOPED ADHESIONS TO INTERNAL ORGANS AND EVISCERATED. A SUBSEQUENT SURGICAL PROCEDURE HAD BEEN PLANNED, BUT NO INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274512 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM DSM BIOMEDICAL 30012-32

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention