BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 2070955 · Received April 19, 2011

    Report

    Report Number
    1213643-2011-00166
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    August 27, 2008
    Report Date
    December 6, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REC'D 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 REC'D. BASED ON A REVIEW OF THE MEDICAL RECORDS, PT WAS TREATED FOR A HERNIA RECURRENCE ON (B)(6) 2008. THE PT'S ATTORNEY ALLEGES THAT SIX YEARS EARLIER, THE PT HAD A COMPOSIX KUGEL MESH IMPLANTED. IN THE MEDICAL RECORDS PROVIDED, THERE IS NO REFERENCE TO OPERATIVE REPORTS OR CT REPORTS IDENTIFYING A COMPOSIX KUGEL PRODUCT, NOR WERE THERE ANY PATHOLOGY REPORTS FOR PARTIALLY EXPLANTED MESH. ADDITIONALLY, THERE WERE NO MEDICAL RECORDS BEYOND (B)(6) 2008 THAT WOULD INDICATE THE PT'S CLINICAL COURSE AFTER THE ALLEGED EVENT. THE PROCEDURE ON (B)(6) 2008 IS SAID TO HAVE BEEN FOR A RECURRENCE, WHICH IS STATED AS A POSSIBLE ADVERSE REACTION IN THE COMPOSIX KUGEL'S INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, IT IS UNK WHETHER THE BARD MESH MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. DAVOL HAS MADE NUMEROUS ATTEMPTS TO OBTAIN MORE INFORMATION AND TO HAVE A SAMPLE RETURNED FOR EVALUATION. THIS MDR CONTAINS ALL THE INFORMATION AVAILABLE TO DATE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON ATTORNEY'S REPORT: (B)(6) 2002 - PT IMPLANTED WITH A COMPOSIX KUGEL MESH PRODUCT. ON (B)(6) 2008 - PARTIAL EXPLANT OF PREVIOUSLY IMPLANTED MESH. HERNIA REPAIR WITH MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC NA 43CMD167

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R| S