BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 2195527 · Received August 2, 2011

    Report

    Report Number
    1213643-2011-00366
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    September 12, 2006
    Report Date
    December 15, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX E/X MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW, THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH BARD MODIFIED KUGEL ON (B)(6) 1998. NEARLY TWO YEARS POST IMPLANT, THE PATIENT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA; HOWEVER, THE OPERATIVE REPORT FROM THAT PROCEDURE WAS NOT INCLUDED IN THE PROVIDED MEDICAL RECORDS. ON (B)(6) 2006, THE PATIENT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH COMPOSIX E/X. DURING THE REPAIR WITH BARD MODIFIED KUGEL WAS IDENTIFIED AND NOTED TO APPEAR TO BE DETACHED LATERALLY. THE BARD MODIFIED KUGEL WAS LEFT IN PLACE. ON (B)(6) 2006, THE PATIENT UNDERWENT EXCISION OF COMPOSIX E/X AND BARD MODIFIED KUGEL PATCH. OMENTAL ADHESIONS WERE LYSED AND NO MESH WAS NOTED TO BE USED TO COMPLETE THE REPAIR. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS NOTED THE PATIENT HAS UNDERGONE FIVE HERNIA REPAIRS WITH ONLY FOUR DOCUMENTED IN THE INCLUDED RECORDS. THE PATIENT WAS TREATED FOR A RECURRENCE AND ADHESIONS, BOTH OF WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2009-00389 FOR INFORMATION RELATED TO THE COMPOSIX E/X MESH IMPLANTED ON (B)(6) 2006. ADDITIONAL PMA/510(K): K021736.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 1998 - PATIENT UNDERWENT REPAIR OF RECURRENT UMBILICAL HERNIA WITH BARD MODIFIED KUGEL PATCH SECONDARY TO EXCISION OF SEBACEOUS CYST ON RIGHT UPPER ARM. ON (B)(6) 2000 - REPAIR OF RECURRENT VENTRAL HERNIA (NO OPERATIVE REPORT INCLUDED). ON (B)(6) 2006 - PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA USING COMPOSIX E/X. BARD MODIFIED KUGEL PATCH WAS IDENTIFIED AND APPEARED TO BE DETACHED LATERALLY; HOWEVER, THE MESH WAS LEFT IN PLACE. ON (B)(6) 2006 - PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH NO MESH NOTED. THE COMPOSIX E/X MESH AND BARD MODIFIED KUGEL PATCH WERE IDENTIFIED AND EXCISED. OMENTAL ADHESIONS WERE LYSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED KUGEL PATCH FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention