BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2821506 · Received October 23, 2012

    Report

    Report Number
    1213643-2012-00727
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    January 10, 2005
    Report Date
    February 24, 2010
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED, THERE IS NO WAY TO DETERMINE IF THE MESH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEMS. THE PT HAS A CO-MORBIDITIES OF OBESITY AND NUMEROUS HERNIA REPAIRS. BETWEEN 2001 AND 2009, THE PT UNDERWENT SEVEN ABDOMINAL HERNIA REPAIRS, UMBILICAL, VENTRAL, INCISIONAL, WITH MULTIPLE MESH IMPLANTS AND EXPLANTS. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR ADHESIONS AND RECURRENCE, WHICH ARE BOTH KNOWN ADVERSE EVENTS LISTED IN THE IFU. A LOT NUMBER WAS NOT PROVIDED, THEREFORE A MFG REVIEW COULD NOT BE PERFORMED. THERE IS NO INDICATION OF DEFECTIVE MESH. NO CULTURES OF PATHOLOGY HAS BEEN PROVIDED, AND NO PRODUCT HAS BEEN RETURNED. IF ANY ADD'L INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. INFO RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2005, WAS REPORTED IN ACCORDANCE WITH RAE 2008-004.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: NI/NI/2001 - PT UNDERWENT UMBILICAL HERNIA REPAIR AND CHOLECYSTECTOMY. NO OPERATIVE REPORT. ON (B)(6) 2002, PT UNDERWENT REPAIR OF RECURRENT UMBILICAL HERNIA WITH IMPLANT OF BARD FLAT MESH (MESH #1). ON (B)(6) 2003, PT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR. PREVIOUSLY IMPLANTED BARD FLAT MESH (MESH #1) WAS PARTIALLY EXPLANTED. DIAPHRAGMATIC HERNIA, WITH PARTIALLY INCARCERATED STOMACH, WAS ALSO REPAIRED, AND LYSIS OF ADHESION WAS PERFORMED. ON (B)(6) 2005, PT UNDERWENT REPAIR OF INCISIONAL VENTRAL HERNIA (SUPRAUMBILICAL AREA) WITH IMPLANT OF A NON-BARD MESH. BARD FLAT MESH (MESH #1) WAS EXPLANTED IN ENTIRELY. LYSIS OF ADHESIONS WAS PERFORMED. AND A SEROSAL TEAR WAS REPAIRED WITH SUTURES. (B)(6) 2005, PT UNDERWENT REPAIR OF VENTRAL HERNIA WITH COMPOSIX KUGEL MESH (MESH #2). NON-BARD MESH WAS EXPLANTED AND LYSIS OF ADHESIONS WAS PERFORMED. NOTED TO HAVE POOR FASCIA. ON (B)(6) 2008, PT UNDERWENT REPAIR OF COMPLEX, RECURRENT VENTRAL HERNIA WITH A NON-BARD MESH IMPLANT. COMPOSIX KUGEL MESH (MESH #2) WAS EXPLANTED. LYSIS OF ADHESIONS WAS PERFORMED. ON (B)(6) 2009, PT UNDERWENT REPAIR OF VENTRAL HERNIA IN LEFT MID ABDOMEN WITH IMPLANT OF BARD DULEX MESH IMPLANT, AND ALSO REPAIR OF VENTRAL HERNIA IN UPPER RIGHT ABDOMEN WITH IMPLANT OF BARD VENTRALEX 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention