BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2062369 · Received April 5, 2011

    Report

    Report Number
    1213643-2011-00133
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 17, 2010
    Report Date
    June 21, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    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 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. BASED ON THE PROVIDED MEDICAL RECORDS, PATIENT WAS TREATED ON (B)(6) 2003 FOR A VENTRAL HERNIA USING A COMPOSIX KUGEL MESH. SEVEN YEARS POST IMPLANT OF THE BARD MESH, THE PATIENT WAS TREATED FOR A RECURRENCE WITH AN ATRIUM C-QUR MESH. THERE IS NO MENTION OF THE PREVIOUS REPAIR, PREVIOUS DEVICE FAILURE, OR ANY EXPLANTATION BEING PERFORMED DURING THAT PROCEDURE. WHILE THERE IS NO MENTION OF THE BARD MESH DURING THAT HERNIA REPAIR OR THAT IT MAY HAVE CONTRIBUTED TO THE EVENT, RECURRENCE IS A POSSIBLE ADVERSE REACTION STATED IN THE COMPOSIX KUGEL'S INSTRUCTIONS FOR USE. THERE IS NO MENTION OF THE BARD PRODUCT AT ANY POINT AFTER ITS IMPLANTATION IN 2003. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER THE BARD PRODUCT MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT; HOWEVER, THE MEDICAL RECORDS PROVIDED DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESH. NO SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, BASED ON THE CURRENTLY AVAILABLE INFORMATION NO BARD MESH DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2003 - REPAIR OF VENTRAL HERNIA USING COMPOSITE KUGEL MESH. ON (B)(6) 2010 - INCISIONAL HERNIA REPAIR WITH ATRIUM C-QUR MESH. SOME ADHESIONS LYSED. NO REFERENCE TO PREVIOUS REPAIR, EXCLUDING MENTION OF PREVIOUS SCAR. FROM (B)(6) 2010 - OFFICE VISITS BULGE IN MID ABDOMEN, PAIN AFTER SHOVELING REPORTED, NO WOUND INDURATION, ERYTHEMA, MASSES, ECCHYMOSIS OR FLUCTUANCE. ON (B)(6) 2010 - SOME HARDNESS NOTED AT SURGERY SITE, ABDOMINAL PAIN WAS SEVERE AFTER SURGERY, BETTER NOW. NO FURTHER PAIN. ON (B)(6) 2010 - DURING OFFICE VISIT, DOCTOR NOTES CT SCAN INDICATING NO RECURRENT HERNIA, SMALL FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC. NA 43JMD3038

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention