BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX

    MDR report key: 2232409 · Received August 26, 2011

    Report

    Report Number
    1213643-2011-00399
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    December 5, 2006
    Report Date
    October 14, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 MEDICAL RECORD REVIEW THE PATIENT UNDERWENT REPAIR OF A RECURRENT INCISIONAL HERNIA WITH COMPOSIX MESH ON (B)(6) 2002. THE MEDICAL RECORDS NOTE, DURING THE REPAIR AN UNSPECIFIED MESH WAS EXCISED. ON (B)(6) 2006, THE PATIENT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH COMPOSIX KUGEL. LYSIS OF ADHESIONS AND A PARTIAL EXCISION OF COMPOSIX MESH WAS PERFORMED. ADDITIONALLY, EXCISION OF LIPOMA LEFT FLANK AND PARTIAL OMENTECTOMY. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS NOTE THAT THE PATIENT HAS A PAST HISTORY OF HERNIA REPAIR. THE INFORMATION PROVIDED INDICATES THE PATIENT DEVELOPED AND WAS TREATED FOR ADHESIONS AND A RECURRENCE, BOTH OF WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. THERE HAS BEEN NO PRODUCT CODE OR LOT NUMBER PROVIDED, THEREFORE A MANUFACTURING REVIEW IS NOT POSSIBLE. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2002-PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX MESH. EXCISION OF UNSPECIFIED MESH. ON (B)(6) 2005-OFFICE VISIT, LARGE DEFECT CONSISTENT WITH RECURRENT HERNIA. ON (B)(6) 2005-OFFICE VISIT, LOWER ABDOMINAL WALL IS LAX. SMALL DEFECTS LEFT OF UMBILICUS AND SYMPHYSIS PUBIC. ON (B)(6) 2006-PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, AND REPAIR OF RECURRENT HERNIA WITH COMPOSIX KUGEL. LYSIS OF ADHESIONS AND PARTIAL EXCISION OF COMPOSIX MESH EXCISION OF LIPOMA LEFT FLANK AND PARTIAL OMENTECTOMY. ON (B)(6) 2009-OFFICE VISIT, ABDOMINAL WALL IS LAXED, POSSIBLE SUPRAUMBILICAL HERNIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention