BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2171336 · Received July 18, 2011

    Report

    Report Number
    1213643-2011-00340
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    May 15, 2007
    Report Date
    February 22, 2008
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    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 A REVIEW OF THE PROVIDED MEDICAL RECORDS, A PATIENT WITH A HISTORY OF OBESITY, TWO C-SECTIONS, A HYSTERECTOMY AND AN APPENDECTOMY UNDERWENT REPAIR OF AN INCISIONAL HERNIA WITH A COMPOSIX KUGEL MESH ON (B)(6) 2006. THE PATIENT REPORTED THAT SHE HAD EXPERIENCED PAIN FOR ABOUT A YEAR AFTER THE IMPLANT. THE MESH, ALONG WITH A PIECE OF PROLENE MESH FROM A PREVIOUS PROCEDURE, WAS EXPLANTED ON (B)(6) 2007. THE OPERATIVE REPORT DOES NOT INDICATE ANY EVIDENCE OF A MESH DEFECT DURING THE EXPLANT PROCEDURE. THE MESH WAS SENT TO PATHOLOGY, WHERE IT WAS STATED THAT "THE PERIPHERAL RIM IS INTACT." A REFERENCE TO A "SMALL POSSIBLE CENTRAL DEFECT" WAS NOT EXPANDED UPON. WE ARE UNABLE TO DETERMINE IF THIS MAY HAVE BEEN A RESULT OF INSTRUMENTATION DURING EXPLANT. NO PHOTOS WERE PROVIDED AND NO SAMPLE WAS RETURNED TO EVALUATE THIS REPORT. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE PATIENT WAS REPORTEDLY TREATED FOR A RECURRENCE, WHICH IS STATED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE OPERATIVE NOTES ALSO REFERRED TO SOME ADHESIONS TO THE MESH. ADHESIONS ARE ALSO LISTED AS A POSSIBLE ADVERSE REACTION IN THE IFU. A MANUFACTURING REVIEW WAS PERFORMED AND DID NOT SHOW EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORD PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2005 - PROLENE MESH IMPLANTED. ON (B)(6) 2006 - INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. ON (B)(6) 2007 - OFFICE VISIT: PATIENT REPORTS PAIN. ON (B)(6) 2007 - EXPLANT OF COMPOSIX KUGEL MESH AND PREVIOUSLY PLACED PROLENE MESH, REPAIR OF RECURRENT INCISIONAL HERNIA. ON (B)(6) 2007 - PATIENT REPORTING PAIN, CULTURES NEGATIVE FOR GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43DPD338

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention