BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2170733 · Received July 12, 2011

    Report

    Report Number
    1213643-2011-00328
    Event Type
    Injury
    Date Received
    July 12, 2011
    Report Date
    May 27, 2009
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX KUGEL MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT REPAIR OF A RECURRENT RIGHT INGUINAL HERNIA WITH BARD FLAT MESH ON (B)(6) 2003. THE PT WAS SEEN POSTOPERATIVELY ON (B)(6) 2003 WITH WOUNDS HEALING WELL AND NO EVIDENCE OF HERNIA RECURRENCE. APPROX EIGHT MONTHS LATER, THE PT WAS SEEN IN AN OFFICE VISIT WITH COMPLAINTS OF PAIN IN THE RIGHT GROIN. UPON EXAMINATION, THERE WAS NO EVIDENCE OF RECURRENCE, THE PT WAS REFERRED TO A PAIN CLINIC AND A PROSTATE BIOPSY WAS SCHEDULED. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS NOTED THERE WAS NO EVIDENCE OF HERNIA RECURRENCE, HOWEVER, THE PT WAS GOING TO HAVE A PROSTATE BIOPSY AFTER EXPERIENCING PAIN. THE MEDICAL RECORDS PROVIDED DO NOT INCLUDE TEST RESULTS FOLLOWING THE SCHEDULED BIOPSY. ADDITIONALLY, THE MESH REMAINS IMPLANTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2009-00181 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2003 - PT UNDERWENT RIGHT INGUINAL HERNIA REPAIR WITH COMPOSIX KUGEL SECONDARY TO A CHOLECYSTECTOMY. THE MEDICAL RECORDS NOTE SOME BILE WAS SPILLED INTO THE ABDOMEN AND WAS IRRIGATED PRIOR TO CLOSURE. ON (B)(6) 2003 - PT EXPERIENCING PAIN, EXAM REVEALS WELL HEALED INCISION. ON (B)(6) 2003 - PT CONTINUES TO COMPLAIN OF PAIN, REFERRED TO PAIN CLINIC. ON (B)(6) 2003 - OFFICE VISIT, POSSIBLE RECURRENCE AFTER COUGHING. ON (B)(6) 2003 - PT UNDERWENT REPAIR OF RECURRENT RIGHT INGUINAL HERNIA WITH BARD FLAT MESH. THE COMPOSIX KUGEL MESH COULD NOT BE VISUALIZED, HOWEVER, MEDICAL RECORDS NOTE IT APPEARED IT MAY HAVE FOLDED AWAY FROM INTERNAL RING. ON (B)(6) 2003 - OFFICE VISIT, WOUNDS HEALING WELL, NO EVIDENCE OF RECURRENCE. PT INSTRUCTED TO MINIMIZE ACTIVITY. ON (B)(6) 2004 - PT EXPERIENCING PAIN, NO EVIDENCE OF RECURRENCE. A PROSTATE BIOPSY WILL BE CONDUCTED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC. NA 43GND472

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention