BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 1864667 · Received October 4, 2010

    Report

    Report Number
    1213643-2010-00428
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    January 16, 2008
    Report Date
    June 21, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K053066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INFECTION OCCURRED SHORTLY AFTER THE (B)(6) 2008 PROCEDURE. 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 1213643-2010-00426 FOR INFORMATION RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    PER INFORMATION EXTRACTED VIA MEDICAL RECORD REVIEW: 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. THE SEPRAMESH IP WAS TAILORED TO SIZE AT THE TIME OF THE IMPLANT AND WAS SEWN LATERALLY TO THE PREVIOUS COMPOSIX KUGEL MESH ALREADY 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 SEPRAMESH IP FTL DAVOL INC., SUB. C.R. BARD, INC. NA 07NPO055

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R