BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1069244 · Received July 1, 2008

    Report

    Report Number
    1213643-2008-00365
    Event Type
    Injury
    Date Received
    July 1, 2008
    Date of Event
    March 9, 2006
    Report Date
    June 11, 2008
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIZE AND LOT NUMBER OF THE MESH, 11 X 14 CM OF LOT 41FLDP11 BELONG TO PRODUCT NUMBER 0010205, NOT A 0010206, WHICH WAS INDICATED IN THE LEGAL COMPLAINT/SUMMONS. THE SUBJECT PRODUCT CODE WILL BE RECORDED. 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: 10/02/2001 - PATIENT UNDERWENT HERNIA REPAIR PROCEDURE DURING WHICH A COMPOSIX KUGEL MESH WAS USED TO REPAIR THE HERNIA DEFECT. IN EARLY 2006, THE PATIENT DEVELOPED AN INFECTION THOUGHT TO BE RELATED TO THE MESH. IN 2006 - THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO HAVE THE MESH REMOVED. THE FIRST LAYER OF THE MESH WAS FOUND TO BE DENSELY ADHERED TO THE ABDOMINAL WALL. THE MESH WAS FILLED WITH A MURKY, INFECTED FLUID. THE BOTTOM LAYER OF THE MESH WAS FOUND TO BE ADHERED TO THE SMALL BOWEL. THE MESH WAS REMOVED AND THE SMALL BOWEL WAS RESECTED. THE PATIENT SUFFERED INJURY, INCLUDING INFECTION PROBLEMS FOR MANY MONTHS FOLLOWING THE REMOVAL OF THE PATCH. THE PATIENT ALSO REQUIRED MULTIPLE FOLLOW-UP SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 41FLDP11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention