BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2787228 · Received October 4, 2012

    Report

    Report Number
    1213643-2012-00656
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    June 12, 2009
    Report Date
    September 13, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMEN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS PREVIOUSLY REPORTED BY THE PATIENTS' ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE ADDITIONAL IMPLANTS AND POSTOPERATIVE EVENTS. BASED ON THE INFORMATION AVAILABLE THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS A PATIENT WITH A MEDICAL/SURGICAL HISTORY SIGNIFICANT FOR COLON CANCER HAVING UNDERGONE A COLOSTOMY AND A COLOSTOMY REVISION AS WELL AS MULTIPLE OTHER ABDOMINAL SURGERIES. APPROXIMATELY, TEN MONTHS POST IMPLANT OF THE PERFIX PLUG AND FLAT MESH THE PATIENT DEVELOPED ANOTHER HERNIA IN THE LLQ. THIS WAS REPAIRED WITH PLACEMENT OF A FLAT MESH OVER THE EXISTING MESH. ALSO NOTED IN THE OPERATIVE REPORT WAS THA THE SAC WAS REMOVED FROM THE SURROUNDING SUBCUTANEOUS TISSUE TO HELP FACILITATE NO RECURRENCE OF THE SEROMA. THERE IS NO OTHER INFORMATION DOCUMENTING THE FORMATION OF A SEROMA; HOWEVER IT APPEARS AS THOUGH THE PATIENT MAY HAVE BEEN TREATED AT SOME POINT FOR SEROMA FORMATION. BOTH SEROMA AND RECURRENCE, ARE KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. 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 MEDICAL RECORDS INDICATE THE MESH REMAINS IMPLANTED. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2008-00221 FOR INFORMATION RELATED TO A COMPOSIX MESH THAT WAS IMPLANTED IN THE PATIENT'S RUQ ON (B)(6) 2001. THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2004 WAS REPORTED TO THE FDA IN ACCORDANCE WITH RAE (B)(4). SEE MDR 1213643-2012-00654 FOR INFORMATION RELATED TO THE PERFIX PLUG IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED PAIN, ADHESIONS, ABSCESS, BOWEL PERFORATIONS, DEFECTIVE MESH. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2004 - REPAIR OF INCARCERATED RECURRENT INCISIONAL HERNIA IN THE LLQ WITH COMPOSIX KUGEL MESH. ON (B)(6) 2007 - PATIENT PRESENTED WITH SEVERE LEFT LOWER ABDOMINAL PAIN AND ELECTED SURGICAL INTERVENTION. EXCISION OF COMPOSIX KUGEL MESH WITH PLACEMENT OF A NON-BARD MESH WAS PERFORMED. MESH ADHESIONS WERE NOTED AND LYSED. ON (B)(6) 2008 -REPAIR OF RECURRENT INCARCERATED INCISIONAL LLQ HERNIA WITH A PERFIX PLUG. REPORTEDLY, THE AREA CONTAINED VERY THIN FASCIA AND FLAT MESH WAS LAID ON TOP OF THE FASCIA AND SECURED. ON (B)(6) 2009 - REPAIR OF INCISIONAL LLQ HERNIA. REPORTEDLY, THE PERFIX PLUG AND THE FLAT MESH WERE LEFT INTACT AND ANOTHER FLAT MESH WAS PLACED AND SUTURED TO THE PREVIOUSLY PLACED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSC0445

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention