BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2163538 · Received November 4, 2010

    Report

    Report Number
    1213643-2010-00475
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    May 2, 2008
    Report Date
    October 14, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K02173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT INDICATES THAT THE PATIENT HAD AND WAS TREATED FOR A RECURRENCE, WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. THE REPORT DOES NOT SPECIFY A SPECIFIC PRODUCT PROBLEM AND NO PRODUCT WAS RETURNED FOR EVALUATION, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFORMATION, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2007 - THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR WITH SUTURES. ON (B)(6) 2007 - THE PATIENT UNDERWENT OPEN OUTPATIENT VENTRALEX MESH IMPLANT PROCEDURE AT THE SITE OF THE PREVIOUS UMBILICAL HERNIA REPAIR SITE. THE MESH WAS SUTURED IN PLACE WITH 2-0 VICRYL SUTURE. ON (B)(6) 2008 - PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY FOR PAINFUL UMBILICAL BULGE. PER THE OPERATIVE REPORT: OMENTAL ADHESIONS WERE NOTED AND ATTACHED TO THE UNDERSIDE OF A 6 CM PIECE OF MESH. THE ADHESIONS WERE TAKEN DOWN AND THE UNDERSIDE OF THE MESH WAS EXAMINED. "IT WAS INTACT BUT IT WAS NOT FIXED. THE ROUND LIGAMENT RAN UNDER IT SUPERIORLY, LIFTING UP THE SUPERIOR BORDER. [THE SURGEON] INCISED THE ROUND LIGAMENT USING ELECTROCAUTERY AND RETRACTED THE MESH CAUDAD TO FIND THAT THE MESH LAY ON THE PERITONEUM. [THE SURGEON] RESECTED THE REMNANT OF THE ROUND LIGAMENT UNDER THE MESH AS WELL AS THE PERITONEUM AROUND IT." A SMALL HERNIA RECURRENCE WAS NOTED ON THE RIGHT SIDE OF THE MESH WHICH MEASURED 5-8 MM. SOME INCARCERATED PREPERITONEAL FAT WAS NOTED. THIS HERNIA WAS REDUCED. THE SURGEON PUT THE MESH BACK INTO PLACE AND FOUND THAT IT PROVIDED GOOD COVERAGE. THE MESH WAS SUTURED BACK INTO PLACE AT THE 3, 6, 9, AND 12 O'CLOCK POSITIONS. CURRENT - THE PATIENT IS CURRENTLY REPORTING PAIN IN THE AREA OF THE PREVIOUS UMBILICAL HERNIA SITES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention