BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1131923 · Received August 22, 2008

    Report

    Report Number
    1213643-2008-00410
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    May 21, 2007
    Report Date
    July 31, 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
    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 PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PROD IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2007 - THE PT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE WITH INPLANT OF A COMPOSIX KUGEL MESH PATCH. AFTER ITS IMPLANTATION, THE MESH CONCRETIZED, MEANING IT HARDENED DUE TO OXIDATION OR OTHER CHEMICAL REACTION WITH SURROUNDING BODILY FLUIDS AND TISSUE. THIS CAUSED PT EXTREME PAIN AND ENABLED ADHESIONS ON THE INTERIOR SURFACE OF THE MESH. ABOUT 2 MONTHS LATER - THE PT UNDERWENT SURGERY TO EXPLANT THE COMPOSIX KUGEL MESH PATCH AND REPLACE WITH A ANOTHER TYPE OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AQD398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention