BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1150537 · Received September 3, 2008

    Report

    Report Number
    1213643-2008-00418
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 6, 2007
    Report Date
    August 4, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: LOT NUMBER INFORMATION PROVIDED, "43LMD" IS INCOMPLETE, AND DOES NOT REPRESENT A LOT OF DAVOL MESH. CURRENTLY, IT IS UNKNOWN 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 RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: 2003 -THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA REPAIR. A 4X4 COMPSIX MESH, LOT NUMBER 43LMD WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IN 2007 -THE PATIENT WAS HOSPITALIZED WITH SEVERE ABDOMINAL PAIN AND DISCOMFORT. THE PATIENT WAS TAKEN IMMEDIATELY TO SURGERY WHERE THE SURGEON DOCUMENTS THAT THE MESH HAD INCARCERATED THE SMALL BOWEL AND ALMOST ERODED INTO THE BOWELL. THE MESH AND THE SMALL BOWEL FORMED A LARGE KNOTTED MASS WHICH HAD TO BE RESECTED WITH A PORTION OF THE SMALL BOWEL REMOVED. FURTHER, DOCUMENTATION BY HIS PHYSICIAN STATES IT WAS OBVIOUS THAT THE MESH HAD PULLED FROM THE FASCIA AND WAS MATTED AND ALMOST ERODING INTO A LOOP OF SMALL BOWEL. PATIENT UNDERWENT SURGERY FOR INCARCERATED INCISIONAL HERNIA, SMALL BOWEL INCARCERATION WITH PRIOR MESH, EXTENSIVE ADHESIONS, REPAIR OF INCARCERATED HERNIA, PARTIAL SMALL BOWEL RESECTION, AND REMOVAL OF PRIOR MESH. AT APPROX 5 DAYS LATER - THE PATIENT AGAIN UNDERWENT SURGERY RELATED TO HIS ORIGINALLY PLACED COMPOSIX HERNIA MESH. THE SURGEON NOTES IN THE OPERATIVE REPORTS THAT IT WAS NOT POSSIBLE TO CLOSE THE WOUND FROM THE 5 DAYS PRIOR SURGERY DUE TO THE COMPLICATIONS FROM THE MESH. IN 2008, THE PATIENT UNDERWENT SURGERY FOR DEHISCENCE OF PRIOR INCISIONAL HERNIA REPAIR, REPAIR OF DEHISCENCE AND REMOVAL OF SMALL LOOP OF BOWEL FROM WITHIN THE DEHISCENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R