BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEHS- COMPOSIX KUGEL

    MDR report key: 982161 · Received January 17, 2008

    Report

    Report Number
    1213643-2008-00167
    Event Type
    Injury
    Date Received
    January 17, 2008
    Date of Event
    May 10, 2007
    Report Date
    December 19, 2007
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETUNED FOR EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY'S REPORT OF PT'S ALLEGED PAIN, ADHESIONS, SEROMA, EXPLANT OF THE MESH AND HOSPITALIZATION DUE TO DEFECTIVE MESH. IN 2004 - PT UNDERWENT HERNIA REPAIR PROCEDURE, DURING WHICH A CK MESH WAS IMPLANTED. THE NEXT MONTH - PT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND FEVER. A CT SCAN WAS PERFORMED AND THE FINDINGS SUGGESTED AN ABSCESS INVOLVING THE MESH AND EXTENDING INTO THE ANTERIOR ABDOMINAL WALL CAVITY. THE PT UNDERWENT CT GUIDED PERCUTANEOUS DRAINAGE OF THE ABSCESS. FOUR DAYS LATER - PT UNDERWENT SURGERY TO EXPLANT THE MESH DUE TO MESH COMPLICATIONS AND THE DEVELOPMENT OF AN ABSCESS. FIVE DAYS LATER - PT UNDERWENT ADDITIONAL SURGERY DUE TO CONTINUED PROBLEMS WITH THE CK MESH AND DRAINAGE OF STOOL FROM HIS SURGICAL WOUND. THE PHYSICIAN NOTES WOUND DRAINING STOOL, LARGE ENTEROCUTANEOUS FISTULA INVOLVING AND ENTEROTOMY IN THE SMALL BOWEL, ORIGINATING FROM A SMALL BOWEL PERFORATIONS, SMALL BOWEL RESECTION PERFORMED, SEGMENTAL RESECTION VENTRAL HERNIORRHAPHY, AND THE VENTRAL HERNIA PORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEHS- COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43GOD237

    Patients

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