BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2537956 · Received April 9, 2012

    Report

    Report Number
    2530154-2012-00003
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 1, 2012
    Report Date
    April 9, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: (OTHER): LOT HISTORY RECORDS REVIEWED. RESULTS CODE: NO DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION. CONCLUSION CODE: INVESTIGATION: THE DEVICE HISTORY RECORDS FOR KNC LOT NUMBER 95654 HAS BEEN REVIEWED. THERE ARE NO DEVIATIONS RELATED TO THE REPORTED FAILURE MODE. LOT NUMBER 95654 IS COMPRISED OF THE LOWER LEVEL, PART NUMBER 6445-32, LOT NUMBER 95332. THE DHR FOR LOT NUMBERS 95332 SHOWS NO DEVIATIONS RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF DEVICE COMPLAINTS REPORTED TO KNC INDICATE NO LIKE COMPLAINTS FOR LOT NUMBER 95654, OR THE LOWER LOT NUMBER 95332. ROOT CAUSE: NO SPECIFIC ROOT CAUSE CAN BE ASSIGNED. THE DEVICE SEGMENTS WHICH TORE COULD NOT BE CONFIRMED TO MEET PRODUCT SPECIFICATIONS BY QUANTITATIVE TESTING. CORRECTIVE ACTIONS: THIS FAILURE IS THE FIRST RECORDED FOR THIS LOT. BASED ON MFG AND DISTRIBUTION DATES, IT IS BELIEVED, BUT NOT KNOWN, THAT ADD¿L DEVICES HAVE BEEN CONSUMED WITHOUT INCIDENT, AND THAT THE RISK FOR RE-OCCURRENCE IS WITHIN ACCEPTABLE LIMITS FOR THIS TYPE OF DEVICE. KENSEY NASH WILL CONTINUE TO MONITOR FOR LIKE RE-OCCURRENCES AND INITIATE APPROPRIATE ACTIONS AS WARRANTED.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A DISTENDED OPEN ABDOMEN. THE SURGEON WAS ABLE TO CLOSE THE ABDOMEN MOST OF THE WAY, BUT THERE WAS STILL A SMALL GAP. HE THEN PLACED XCM BIOLOGIC AS AN OVERLAY AND ATTACHED THE EDGES USING A RUNNING STITCH. TWO DAYS LATER, WHILE THE PT WAS STILL IN THE HOSPITAL, THE DEVICE TORE ALONG THE ENTIRE EDGE. THE DEVICE WAS EXPLANTED. NO OUTCOME INFO IS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. 30010-32 95654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE SUTURE