BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH

    MDR report key: 1150467 · Received September 5, 2008

    Report

    Report Number
    1213643-2008-00425
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 18, 2007
    Report Date
    August 6, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    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. WHILE RECURRENCE AND ADHESIONS ARE KNOWN ADVERSE EVENTS THAT ARE LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE. SEE MEDWATCH 1213643-2008-00424 FOR INFO RELATED TO THE OTHER MESH IMPLANTED IN 2002.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2002 - THE PT WAS IMPLANTED WITH TWO DAVOL COMPOSIX DUAL MESHES, TO REPAIR A POSTOPERATIVE VENTRAL HERNIA. AFTER IMPLANTATION, PT'S TRANSVERSE COLON ADHERED TO THE UPPER MIDLINE COMPOSIX MESH AND HERNIA DEFECTS RECURRED AROUND THE EDGES OF THE MESHES. IN EARLY 2007 - PT'S ATTENDING SURGEON DECLINED TO EXPLANT THE ADHERENT MESH BECAUSE THE ADHESIONS WERE TOO GREAT TO EXCISE, FOR FEAR OF OPENING THE COLON. INSTEAD OF EXPLANTING, THE SURGEON WAS FORCED ON INSERT TWO ADDITIONAL PROLENE MESHES TO COMPENSATE FOR THE FAILURE OF THE COMPOSIX MESHES. ON THE PT'S INFO AND BELIEF, THE COMPOSIX MESHES "DELAMINATED AND/OR HARDENED CAUSING ADHESIONS TO THE COLON AND CAUSING RECURRENT HERNIAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention