BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2062366 · Received April 5, 2011

    Report

    Report Number
    1213643-2011-00136
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    April 23, 2003
    Report Date
    March 29, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS TREATED FOR THREE MIDLINE VENTRAL UMBILICAL HERNIAS WITH BARD COMPOSIX MESH PRODUCTS. THERE WERE NO INFECTIONS OR POST OP COMPLICATIONS NOTED. THE PATIENT WAS TREATED IN 2003 FOR A RECURRENCE THAT OCCURRED BETWEEN TWO AREAS OF SMALL BOWEL THAT WERE ADHERENT TO PREVIOUSLY PLACED MESH. THE PATIENT HAD ALSO HAD ADHESIONS LYSED DURING THE IMPLANTATION OF THE THREE BARD MESHES IN 2002. DURING THE RECURRENCE REPAIR, THERE WAS A PARTIAL EXPLANT OF MESH, HOWEVER IT IS UNCLEAR WHICH MESH WAS AFFECTED. WHILE THERE IS NO INDICATION THAT THE BARD MESH PRODUCTS CONTRIBUTED TO THE ADHESIONS OR RECURRENCE, THEY ARE LISTED AS A POSSIBLE ADVERSE REACTIONS IN THE PRODUCT'S INSTRUCTIONS FOR USE. EIGHT YEARS POST IMPLANT THE PATIENT WAS TREATED FOR AN ENTEROCUTANEOUS FISTULA WITH AN EXTENSIVE CONTAMINATION FORMING ABSCESS AND INFECTION OF THE MESH. A LARGE PIECE OF MESH WAS EXPLANTED. THERE WAS NO PATHOLOGY REPORT FOR EXPLANTED MESH. ALTHOUGH INFECTION IS STATED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S IFU, THE MEDICAL RECORDS PROVIDED DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESHES. BASED ON THE INFORMATION AVAILABLE, IT IS UNCLEAR WHETHER THE BARD MESH MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. NO SAMPLES HAVE BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. REFER TO MDR 1213643-2010-00523 AND MDR 1213643-2011-00135 FOR THE TWO OTHER MESHES IMPLANTED ON (B)(6) 2002.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2001 - LAPAROSCOPIC APPENDECTOMY WITH TWO DRAINS PLACE. NECROTIC APPENDIX. SEVERE GANGRENOUS NECROSIS. ON (B)(6) 2002 - LAPAROSCOPIC REPAIR OF THREE VENTRAL MIDLINE UPPER ABDOMEN INCISIONAL HERNIA REPAIR WITH THREE BARD COMPOSIX MESHES. ADHESIONS TAKEN DOWN. ON (B)(6) 2003 - LAPAROSCOPIC ASSISTED OPEN VENTRAL UMBILICAL INCISIONAL HERNIA REPAIRED WITH BARD COMPOSIX KUGEL MESH. LYSIS OF ADHESIONS PERFORMED. PARTIAL EXCISION OF PREVIOUS MESH. UNREMARKABLE INSERTION TACK AND CLOSURE. ON (B)(6) 2010 - ENTEROCUTANEOUS FISTULA STATUS POST ABDOMINAL REPAIR WITH PROSTHETIC MESH. COLON RESECTION. SMALL BOWEL RESECTION. ADHESIONS TAKEN DOWN. REPAIR MADE WITH BIOLOGIC XENOGRAFT DERMAL MATRIX. REMOVAL OF INFECTED MESH. COLOSTOMY PERFORMED. LARGE AREA OF INFECTION THAT INVOLVED PERITONEAL SPACE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC NA 43ELD177

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention| S