BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2901328 · Received December 17, 2012

    Report

    Report Number
    1213643-2012-00874
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    October 24, 2006
    Report Date
    December 3, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT DEGREE THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED POST OPERATIVE PAIN. IT APPEARS THAT THIS PATIENT HAS UNDERGONE MULTIPLE ABDOMINAL SURGERIES AND HAS DEVELOPED CHRONIC ABDOMINAL PAIN. MEDICAL EXAMS REVEALED NO DEFINITE ETIOLOGY FOR THE SOURCE OF HER PAIN. IT WAS NOTED THAT THE PATIENT'S NUMBNESS IN THE AREA OF THE HERNIA REPAIR MAY BE DUE TO AN INJURY TO THE ILIOINGUINAL NERVE. THERE WERE NO LABORATORY OR RADIOLOGY RESULTS PROVIDED. THREE YEARS POST IMPLANT THE PATIENT UNDERWENT LYSIS OF ADHESIONS; THE MEDICAL RECORDS TO NOT SPECIFICALLY SAY THESE WERE MESH ADHESIONS; HOWEVER ADHESIONS IS LISTED IN THE IFU AS A KNOWN ADVERSE EVENT. A MANUFACTURING REVIEW THAT INCLUDED REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, THE MESH REMAINS IMPLANTED. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) WAS RECEIVED ALLEGING DEFECTIVE MESH, PERMANENT NERVE INJURY, NUMBNESS, ADDITIONAL SURGERY, RECURRENCE, INFECTION AND PAIN. MEDICAL RECORDS WERE SUBSEQUENTLY PROVIDED BY THE PATIENT AND THE FOLLOWING INFORMATION WAS OBTAINED: (B)(6) 2006 - REPAIR OF INGUINAL HERNIA WITH A BARD PERFIX PLUG. (B)(6) 2009 - WITH AN INDICATION OF CHRONIC RLQ PAIN AND A HISTORY OF GESTATIONAL TROPHOBLASTIC DISEASE. THE PATIENT UNDERWENT DILATATION AND CURETTAGE FOLLOWED BY HASSON OPEN LAPAROSCOPY WITH A LAPAROSCOPIC LYSIS OF ADHESIONS AND LAPAROSCOPIC APPENDECTOMY. THE PATIENT WAS FOUND TO HAVE FECALITH OF THE APPENDIX RESULTING IN THE APPENDECTOMY. THE PATIENT'S MESH WAS VISUALIZED AND NOTED TO BE PROTRUDING INTO THE PERITONEAL CAVITY THE SURGEON NOTED THIS "MIGHT BE CONTRIBUTING TO PATIENT'S GROIN PAIN." HOWEVER, THE MESH WAS NOT MANIPULATED RATHER IT WAS NOTED THAT THE PATIENT WOULD BE REFERRED TO GENERAL SURGERY FOR EVALUATION. (B)(6) 2010 - CHOLECYSTECTOMY, LYSIS OF ADHESIONS. UPON EXAMINATION OF THE PATIENT'S RLQ, THE MESH WAS VISUALIZED; A PORTION OF OMENTUM WAS PLACED UNDER THE MESH, SO THERE WAS NO DIRECT CONTACT WITH THE INTESTINE. (B)(6) 2010 - PRESENTS TO THE EMERGENCY ROOM WITH CHEST AND BACK PAIN. EXAM WAS NEGATIVE. (B)(6) 2010 - OFFICE VISIT FOR 2ND OPINION REGARDING HER HERNIA REPAIR. IMPRESSION: REPAIR APPEARS TO BE INTACT. THERE IS SOME NUMBNESS IN THE AREA, "WHICH MAY BE DUE TO AN INJURY TO AN INJURY TO THE ILIOINGUINAL NERVE." NO SURGICAL INTERVENTION IS RECOMMENDED. MD ADVISES HER TO CONSULT WITH THE ORIGINAL SURGEON SHOULD SHE HAVE ANY MORE QUESTIONS REGARDING THE MESH. (B)(6) 2011 - PATIENT RETURNS APPROXIMATELY TEN MONTHS LATER WITH COMPLAINTS OF OCCASIONAL SHOOTING PAINS IN THE LLQ. SHE ALSO HAS BILATERAL LOWER BACK PAIN. REPORTEDLY, "THE ETIOLOGY OF THE LEFT GROIN PAIN IS UNCLEAR BUT MAY BE RELATED TO WHATEVER PROBLEMS SHE MAY BE HAVING FROM A RENAL STANDPOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability