BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3902198 · Received June 20, 2014

    Report

    Report Number
    1213643-2014-00196
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    September 21, 2010
    Report Date
    May 23, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL RECORDS INDICATE THAT THE PATIENT, DEVELOPED A RECURRENCE OF HIS HERNIAS AND UNDERWENT REPAIR. RECURRENCE IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. ADDITIONALLY, THE PATIENT IS OBESE WITH A HISTORY OF HERNIA RECURRENCE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSION CAN BE MADE. SEE MDR 1213643-2014-00153 FOR INFORMATION RELATED TO THE UNKNOWN FLAT MESH IMPLANTED ON (B)(6) 2004. SEE MDR 1213643-2014-00152 FOR INFORMATION RELATED TO BARD COMPOSIX KUGEL HERNIA PATCH IMPLANTED ON (B)(6) 2004. SEE MDR 1213643-2014-00195 FOR INFORMATION RELATED TO THE BARD FLAT MESH IMPLANTED ON (B)(6) 2009.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT. ON (B)(6) 2004 - PATIENT WAS IMPLANTED WITH AN UNKNOWN BARD COMPOSIX KUGEL HERNIA PATCH. (OPERATIVE REPORT NOT PROVIDED CK ALLEGED BY PATIENT). ON (B)(6) 2004 - PATIENT WAS IMPLANTED WITH AN UNKNOWN BARD FLAT MESH FOR REPAIR OF NEW HERNIA JUST ABOVE THE PREVIOUSLY REPAIR. ON (B)(6) 2009 - PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA, WITH THE IMPLANT OF A BARD COMPOSIX LP MESH AND BARD FLAT MESH. INFLAMMATION WAS NOTED AND THE REMOVAL OF ALL PREVIOUSLY PLACED MESH AND "CORKSCREW TACKING SUTURES." ON (B)(6) 2010 - PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIAS ONE OF WHICH WAS NOTED TO CONTAIN SMALL BOWEL. DURING THIS PROCEDURE A BARD COMPOSIX LP MESH WAS PLACED AND SECURED WITH A RUNNING SUTURE USING ANTERIOR MESH PLEDGETS MADE A BARD FLAT MESH CUT TO SIZE. BASED ON MEDICAL RECORD REVIEW THE PREVIOUSLY PLACED BARD COMPOSIX LP MESH AND A BARD FLAT MESH REMAIN IMPLANTED AS THEY WERE NOT REPORTED AS BEING REMOVED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363394 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSB0059

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention