BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2062347 · Received April 5, 2011

    Report

    Report Number
    1213643-2011-00132
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 4, 2010
    Report Date
    April 22, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 (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. BASED ON A REVIEW OF MEDICAL RECORDS, PATIENT HAS UNDERGONE 3 ABDOMINAL HERNIA REPAIRS WITH BARD MESH IMPLANTS. SHE HAS A HISTORY OF RECURRENT HERNIAS. THE FIRST PROCEDURE NOTED IN THE MEDICAL RECORDS ON (B)(6) 2008 REFERS TO A "VERY LARGE VENTRAL HERNIA. IT IS ENCOMPASSING ALMOST THE ENTIRE UPPER PORTION OF THE MIDLINE INCISION." THERE WERE MULTIPLE ADHESIONS LYSED DURING THAT REPAIR. THE PROCEDURE ON (B)(6) 2010 ALSO SHOWED EXTENSIVE ADHESIONS AND REVEALED MULTIPLE VENTRAL HERNIAS. THE THIRD REPAIR PROCEDURE FOUND "MULTIPLE SWISS CHEESE-LIKE DEFECTS IN THE MIDLINE OF THE ABDOMINAL INCISION." NOTATIONS FROM THE OPERATIVE REPORT SAY THAT THE COMPOSIX MESH FAILED. HOWEVER, NO SPECIFIC DEVICE FAILURE IS MENTIONED. THE SURGEON GOES ON TO STATE THAT THE MESH HAD SEPARATION AT THE LATERAL BORDERS TO THE LEFT OF THE MIDLINE, PREDOMINATELY WHERE THE MULTIPLE DEFECTS ARE RECURRENT, WHICH SUGGESTS THE FAILURE INDICATED IS IN REFERENCE TO THE HERNIA RECURRENCE, NOT A SPECIFIC FAILURE OF THE DEVICE. RECURRENCE, HOWEVER, IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTION FOR USE. THE ONLY REFERENCE TO REMOVAL OF MESH DURING THAT PROCEDURE IS A NOTATION THAT OLD MESH AND SUTURE MATERIAL WERE EXCISED BACK TO HEALTHY FASCIA. THERE IS NO REFERENCE OR PATHOLOGY REPORT THAT INDICATES HOW MUCH OF THE MESH WAS REMOVED. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER THE BARD MESH CONTRIBUTED TO THE ALLEGED EVENT. NO SAMPLE HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. REFER TO MDR 1213643-2011-00134 FOR THE MESH IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2008: PT UNDERWENT LARGE VENTRAL HERNIA REPAIR WITH MESH. ADHESIONS TAKEN DOWN. ON (B)(6) 2009: PT UNDERWENT EXPLORATORY LAPAROTOMY, REPAIR OF MULTIPLE VENTRAL HERNIAS WITH A COMPOSIX MESH, LYSIS OF EXTENSIVE ADHESIONS INVOLVING THE OLD MESH, OLD DISSECTION AND HYSTERECTOMY. ON (B)(6) 2009: PT DIAGNOSED WITH RECURRENT HERNIA. ON (B)(6) 2010: PT UNDERWENT REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH VENTRIO MESH. OLD MESH, SUTURES EXCISED BACK TO HEALTHY FASCIA. ON (B)(6) 2010: PT REPORTS SHARP PAIN RIGHT SIDE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA HUSL1391

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention