BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2032327 · Received March 22, 2011

    Report

    Report Number
    1213643-2011-00100
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    December 14, 2005
    Report Date
    November 29, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS, THERE IS NO INDICATION THAT THE BARD VENTRALEX MESH PRODUCTS WERE REMOVED DUE TO DEVICE FAILURE. THE MESHES WERE REMOVED TO AVOID THE RISK OF INFECTION AFTER BEING EXPOSED DURING AN UNRELATED PROCEDURE. ADDITIONALLY, THE PT HAS A HISTORY OF HERNIA RECURRENCE, WHICH IS A KNOWN ADVERSE REACTION STATED IN THE DEVICE'S INSTRUCTION FOR USE. ACCORDING TO A DOCTOR'S REPORT, THE PT "WILL GO TO A BARIATRIC SURGERY SEMINAR. I SUGGESTED TO HER SHE REALLY NEEDS TO LOSE WEIGHT IF SHE EXPECT THE HERNIA REPAIR TO WORK." THE MEDICAL RECORDS PROVIDED DID NOT INCLUDE A STATEMENT OR INDICATION THAT THERE WAS A POSSIBLE OR SUSPECT DEVICE FAILURE RELATED TO THE BARD MESH. NO SAMPLE WAS RETURNED FOR EVAL; HOWEVER, BASED ON THE CURRENTLY AVAILABLE INFO, NO BARD MESH DEVICE FAILURE OCCURRED. REFER TO MDR 1213643-2011-00099 FOR THE VENTRALEX MESH IMPLANTED ON (B)(6) 2004, AND EXPLANTED ON (B)(6) 2005.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2004 - DIAGNOSTIC LAPAROSCOPY. PARTIAL OMENTECTOMY AND UMBILICAL HERNIA REPAIR WITH MESH. VENTRALEX MESH USED TO REPAIR MULTIPLE SMALL HERNIA DEFECTS, WHICH THE SURGEON CONNECTED. ON (B)(6) 2005 - REPAIR OF RECURRENT INCISION HERNIA. PREVIOUS C-SECTION INCISION OPENED, HERNIA SAC DISSECTED FREE FROM SURROUNDING SOFT TISSUE AND OPENED WITH CONTENTS EVENTUALLY REDUCED. VENTRALEX MESH PLACED IN ABDOMINAL CAVITY. ON (B)(6) 2005 - CHILD DELIVERY VIA PT'S THIRD C-SECTION, TUBAL LIGATION, RECURRENT HERNIA REPAIR. DURING THE CESAREAN SECTION, THE TWO VENTRALEX MESHES WERE EXPOSED. ONCE C-SECTION AND TUBAL LIGATION HAD BEEN PERFORMED AND THE UTERUS HAD BEEN CLOSED, DECISION WAS MADE TO REMOVE MESHES TO LIMIT RISK OF INFECTION AFTER EXPOSURE. DURING PROCEDURE, OMENTUM OBSERVED TO BE SEALING OFF BOTH HERNIA SITES. ABNORMAL AREA OF OMENTUM CLAMPED AND LIGATED. THE PT WAS NOTED AS HAVING NO PROBLEMS RELATIVE TO THE MESH REMOVAL. ON (B)(6) 2007 - RECURRENT HERNIA REPAIR. LARGE HERNIA SAC DISSECTED. MOST CONTENTS WERE REDUCED WITH THE EXCEPTION OF LARGE PORTION OF OMENTUM, WHICH HAD TO BE CLAMPED AND LIGATED. UNK "BARD CIRCLE TYPE MESH" USED IN REPAIR. PT TAKEN TO RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC. NA 43FPD459

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention