BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2103729 · Received May 16, 2011

    Report

    Report Number
    1213643-2011-00223
    Event Type
    Injury
    Date Received
    May 16, 2011
    Report Date
    February 23, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 RECEIVED ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. BASED ON A REVIEW OF THE PROVIDED MEDICAL RECORDS, A (B)(6) PT WAS TREATED FOR A RIGHT INGUINAL HERNIA WITH A BARD KUGEL PATCH ON (B)(6) 2005. THE "CONTRAINDICATIONS" SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE STATE: "DO NOT USE THE BARD KUGEL HERNIA PATCH IN INFANTS OR CHILDREN, WHEREBY FUTURE GROWTH WILL BE COMPROMISED BY USE OF SUCH MESH MATERIAL." THE MEDICAL RECORDS PROVIDED DO NOT INDICATE THAT THERE WAS A FAILURE OF THAT DEVICE DURING THAT PROCEDURE, NOR DO THOSE RECORDS EXTEND BEYOND THE IMPLANT. A NOTE IN THE MEDICAL RECORDS ALSO REFERS TO ANOTHER HERNIA SURGERY PERFORMED ABOUT SIX YEARS EARLIER. NO OPERATIVE REPORT FOR THAT PROCEDURE WAS AVAILABLE IN THE PROVIDED RECORDS. WITH THE INFO AVAILABLE, THERE IS NO WAY TO EVALUATE THE ATTORNEY'S CLAIM THAT THE PT SUFFERED INJURIES AS A RESULT OF HAVING THE MESH IMPLANTED. NO SPECIFIC DEVICE FAILURE WAS ALLEGED AND NO SAMPLE HAS BEEN RETURNED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2005 - PT UNDERWENT REPAIR OF A RIGHT INGUINAL HERNIA WITH A BARD KUGEL PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC. NA 43BPD232

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention