BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3594761 · Received January 10, 2014

    Report

    Report Number
    2530154-2013-00014
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 10, 2013
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: EVALUATION OF THIS EVENT IS LIMITED TO MEDICAL ASSESSMENT OF THE COMPLAINT NARRATIVE. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE COMPANY. TO DATE, THE COMPANY HAS MADE MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE LOT NUMBER, BUT IT HAS NOT BEEN PROVIDED. THEREFORE, LOT HISTORY RECORDS COULD NOT BE REVIEWED. IF THE LOT NUMBER BECOMES AVAILABLE AFTER THE SUBMISSION OF THIS INITIAL REPORT, THE LOT HISTORY RECORDS WILL BE EVALUATED AND THE RESULTS WILL BE REPORTED TO FDA IN A F/U REPORT. CONCLUSION: EARLY POSTOPERATIVE BOWEL OBSTRUCTION AFTER ABDOMINAL SURGERY CAN OCCUR WITHOUT MESH, OR WITH ANY MESH PRODUCT, SYNTHETIC OR BIOLOGIC, PERMANENT OR ABSORBABLE. THE BOWEL OBSTRUCTION IS MOST LIKELY RELATED TO PATIENT FACTORS.

    Description of Event or Problem · 1

    THIS PATIENT PRESENTED WITH A RECURRENT, LARGE VENTRAL HERNIA WITHOUT BOWEL OBSTRUCTION. THE NEW HERNIA WAS LOCATED ABOVE THE MARLEX MESH IN THE MIDLINE WITH SYMPTOMS AND OVERALL LAXITY OF ENTIRE ABDOMINAL WALL. SURGERY INCLUDED EXCISION OF THE MARLEX MESH AND INLAY OF XCM BIOLOGIC UNDER THE RECTUS MUSCLES WITH INTERRUPTED SUTURES, FOLLOWED BY ADVANCEMENT OF THE RECTUS MUSCLES TO MIDLINE AND OVERLAY MESH (SANDWICH TECHNIQUE). THREE DRAINS WERE PLACED (ONE IN BETWEEN MUSCLES, TWO IN SUBCUTANEOUS TISSUES. THE PATIENT WAS DISCHARGED 5 DAYS LATER AND WAS DOING WELL. SHE HAD A BOWEL MOVEMENT AT HOME. THREE DAYS LATER, SHE HAD DISTENSION AND NAUSEA WITH A LOW GRADE TEMPERATURE. SHE WAS ADMITTED AND HAD AN OROGASTRIC TUBE PLACED WITH SEVERAL LITERS OF BILIOUS DRAINAGE. SHE WAS TAKEN BACK TO THE OPERATING ROOM AND FOUND TO HAVE ADHESION OF THE ENTIRE BOWEL TO XCM GRAFT. NO PERFORATION WAS OBSERVED. THERE WERE NO SUTURES WHICH HAD CAUGHT THE BOWEL. THE ADHESION CAUSED A POINT OF FIXATION WHERE THE SMALL BOWEL OBSTRUCTED (MECHANICAL OBSTRUCTION). THE PATIENT WAS STARTED ON IV ANTIBIOTIC. XCM WAS EXPLANTED AND THE MUSCLES WERE REPAIRED. THE PATIENT WAS DISCHARGED 5 DAYS LATER AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19448 XCM BIOLOGIC TISSUE MATRIX OKY - MESH, SURGICAL, COLLAGEN, LG ABDOM FTM DSM BIOMEDICAL 30010-32

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R