BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 1864690 · Received October 4, 2010

    Report

    Report Number
    1213643-2010-00426
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    January 19, 2008
    Report Date
    December 21, 2009
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR AN INFECTION. AS THE INFECTION OCCURRED SHORTLY AFTER THE (B)(6) 2008 PROCEDURE AND BECAUSE THE COMPOSIX KUGEL MESH HAD BEEN IMPLANTED MORE THAN THREE YEARS PRIOR TO THE ONSET OF THE INFECTION, IT IS NOT LIKELY THAT THE COMPOSIX KUGEL MESH CAUSED THE INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." SEE MDR 1213643-2010-00425 FOR INFORMATION RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2006. SEE MDR 1213643-2010-00428 FOR INFORMATION RELATED TO THE SEPRAMESH/IP MESH IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: TWO COMPOSIX KUGEL IMPLANTS, HERNIA RECURRENCE, PAIN AND POSSIBLE KINKED MESH RING OF ONE OF THE TWO IMPLANTED MESHES. PER MEDICAL RECORDS RECEIVED; ON (B)(6) 2004- INCISION HERNIA REPAIR WITH COMPOSIX KUGEL MESH. ON (B)(6) 2005- BULGING ON ABDOMINAL WALL; NO PALPABLE SIGN OF HERNIA, NO DISCOMFORT. ON (B)(6) 2005-RECURRENT INCISIONAL HERNIA. ON (B)(6) 2006-RECURRENT HERNIA REPAIR WITH COMPOSIX KUGEL. PREVIOUS MESH WAS INTACT. SUBSEQUENT OFFICE VISITS, NO INFECTION, PROBABLE SEROMA AROUND GRAFT. ON (B)(6) 2006-PAIN AND DISCOMFORT. AREA MEDIALLY WHERE MESH COULD BE FELT, MAY BE CALCIFIED OR BEEN DISPLACED. ON (B)(6) 2006-OFFICE VISIT. GRAFT APPEARED TO BE BUNCHED UP. ON (B)(6) 2007- REMOVAL OF ((B)(6) 2006) COMPOSIX KUGEL MESH & PLACEMENT OF PROCEED MESH. PATCH EASILY PALPABLE THROUGH ANTERIOR ABDOMINAL WALL; CAUSED PAIN AT PLACE THAT HAD APPARENTLY KINKED. ON (B)(6) 2007-OFFICE VISIT NOTED RECURRENT INCISIONAL HERNIA. ON (B)(6) 2008- INCISIONAL HERNIA REPAIR WITH SEPRAMESH IP IMPLANT TO REINFORCE COMPOSIX KUGEL IN LOWER MIDLINE. PATCH TORN AWAY FROM FASCIA MEDIALLY. NO SIGN OF HERNIA SURROUNDING IT, THREE SIDES HERNIA REPAIR WAS ADEQUATE & MESH IN PLACE. ON (B)(6) 2008- INCISION AND DRAINAGE, IRRIGATION, PLACEMENT OF JP DRAIN OVER HERNIA PATCH, INFECTED SEROMA AROUND PREVIOUSLY PLACED HERNIA PATCH. ON (B)(6) 2008- REMOVAL OF PROSTHETIC MESH, WOUND IRRIGATION, ALLODERM. CULTURE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43KPD397

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R