BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2772064 · Received September 28, 2012

    Report

    Report Number
    1213643-2012-00633
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    October 11, 2002
    Report Date
    March 6, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS PREVIOUSLY REPORTED BY THE PT'S ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE ADDITIONAL IMPLANTS AND POSTOPERATIVE EVENTS. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS MORBIDLY OBESE PT WITH A BMI GREATER THAN 47.5, HE HAS A LONG HISTORY OF CIGARETTE USE AND ABUSE OF MULTIPLE SUBSTANCES. HE ALSO HAS A HISTORY OF NON-COMPLIANCE WITH TREATMENT. HE UNDERWENT A GASTRIC BYPASS AND A CHOLECYSTECTOMY IN 2000 AND 2001 RESPECTIVELY. ON THE DATE OF IMPLANT NO HERNIA WAS DETECTED PREOPERATIVELY HOWEVER WHILE UNDERGOING A COMPLEX PANNICULECTOMY THE SURGEON IDENTIFIED SEVERAL SMALL AREAS OF HERNIATION. "THESE AREAS WERE CHARACTERIZED BY ALMOST LIKE A CRIBIFORM MESH WITH WEAKNESS." AFTER A PRIMARY REPAIR FLAT MESH WAS USED TO REINFORCE THE CLOSURE. FOUR MONTHS LATER THE PT HAD DEVELOPING WOUND BREAKDOWN AND MESH EXPOSURE. THE MESH WAS EXCISED AND THE POST OPERATIVE DIAGNOSIS WAS "INFECTED" MESH. WHILE THERE IS NO INDICATION THAT THE MESH WAS THE SOURCE OF THE REPORTED INFECTION, THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." THERE WAS NO LOT NUMBER INCLUDED IN THE MEDICAL RECORDS PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. IF ADDITIONAL EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. IN 2003 AND 2005, THE PT UNDERWENT ADDITIONAL BARD MESH IMPLANTS AND POSTOPERATIVE EVENTS: SEE MDR 1213643-2007-00718 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED PAIN, INFECTION EXPLANT. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2002 - COMPLEX PANNICULECTOMY. DURING THIS PROCEDURE SEVERAL SMALL AREAS OF HERNIATION WERE IDENTIFIED. THE HERNIAS WERE DISSECTED AND CONNECTED TO CREATE ONE LARGE DEFECT. THE DEFECT WAS CLOSED WITH SUTURES AND DUE TO THE PERCEIVED LAXITY IN THE AREA A FLAT MESH WAS PLACED TO REINFORCE THE CLOSURE. ON (B)(6) 2002 - PT PRESENTED FOR SURGERY WITH A HISTORY OF AFTER HAVING PREVIOUS SURGERY, IN MANAGEMENT OF COMPLICATIONS OF MORBID OBESITY, DEVELOPED WOUND BREAKDOWN AND EXPOSURE OF MESH. HE UNDERWENT DEBRIDEMENT, EXCISION OF INFECTED MESH, AND LAYERED CLOSURE OF WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention