BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7304230 · Received February 28, 2018

    Report

    Report Number
    1213643-2018-00424
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    September 18, 2014
    Report Date
    October 16, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K024008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE #1 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT "AN ADDITIONAL SURGERY TO REPAIR RECURRENT INCARCERATED UMBILICAL HERNIA". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 2 YEARS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE THEREBY UNDERWENT REPAIR. THIS SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT MESH - VENTRALEX (DEVICE #1). AN ADDITIONAL SUPPLEMENTAL EMDR HAS BEEN SUBMITTED TO REPRESENT MESH - VENTRALEX (DEVICE #2). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #1), REFERENCE NUMBER (B)(4), LOT NUMBER HUWE1063 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #2), REFERENCE NUMBER (B)(4), LOT NUMBER HUYD0527 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT ANOTHER ADDITIONAL SURGERY TO REPAIR RECURRENT SUPRAUMBILICAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA PATCH. PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SACS WERE SEPARATED FROM SURROUNDING ADHESIONS, CONTAINING OMENTUM AND PREPERITONEAL FAT WHICH WERE EXCISED. A SMALL VENTRALEX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED TO THE OVERLYING FASCIA.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿VISIBLE HERNIA LOCATED ON THE SUPERIOR RIM OF THE UMBILICUS. A FIBROTIC HERNIA SAC CONTAINED OMENTUM IN IT AND THE FASCIAL DEFECT WAS MUCH SMALLER THAN THE HERNIATED OMENTAL CONTENTS WHICH WERE REDUCED. A ROUND VENTRIO TYPE COMPOSITE MESH (VENTRALEX - DEVICE #2) WAS PLACED ON THE UNDERSIDE OF THE FASCIA AND UNDERNEATH THE CIRCULAR DEFECT. APPROXIMATELY 16 SUTURES WERE USED TO ANCHOR THE MESH TO THE UNDERSIDE OF THE ABDOMINAL WALL MUSCULATURE. THE WOUND WAS THEN REAPPROXIMATED BY BRINGING TOGETHER FAT OVER THE EXPOSED MESH WITH SUTURES.¿ (NOTE, NO MENTION/VISUALIZATION OF DEVICE #1 DURING THIS REPAIR) (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT SUPRAUMBILICAL HERNIA THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿THE PALPABLE HERNIA DEFECT WAS LOCATED TO LEFT OF MIDLINE AND JUST ABOVE THE INCISION NEAR UMBILICUS. A HERNIA DEFECT WAS ENCOUNTERED AT THE 2¿O CLOCK POSITION TO CIRCULAR MESH (DEVICE #2) THAT WAS PREVIOUSLY EMPLOYED, IT APPEARED TO CONTAIN PREPERITONEAL OR OMENTAL FAT. IT WAS FREED FROM SURROUNDING ADHESIONS AND REDUCED BACK INTO ABDOMEN AND FASCIA WAS REATTACHED TO THE MESH WITH SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE #1 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT "AN ADDITIONAL SURGERY TO REPAIR RECURRENT INCARCERATED UMBILICAL HERNIA". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. THIS EMDR REPRESENTS THE BARD DEVICE #1 IMPLANTED ON (B)(6) 2012. AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE #2 IMPLANTED ON (B)(6) 2014. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #1), REFERENCE NUMBER 0010301, LOT NUMBER HUWE1063 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #2), REFERENCE NUMBER 0010301, LOT NUMBER HUYD0527 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT ANOTHER ADDITIONAL SURGERY TO REPAIR RECURRENT SUPRAUMBILICAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146959 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWE1063 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Disability| R