BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7266046 · Received February 13, 2018

    Report

    Report Number
    1213643-2018-00252
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    February 13, 2017
    Report Date
    July 31, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. HERNIA RECURRENCE AND INFLAMMATION ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT FEW MONTHS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, FLUID DISCHARGE, ADHESIONS, INFLAMMATION, SCAR TISSUE, ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESIONS AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4(UDI NO), E3, G1, G3, G6, H2, H6, H10. 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. H3 OTHER TEXT: NOT RETURNED.

    Description of Event or Problem · 0

    IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6)2016, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. AS REPORTED, A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER (B)(4) LOT NUMBER HUZC0641 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT HERNIA DEFECT DUE TO AN INFLAMMATORY REACTION TO THE VENTRALEX ST MESH AND THE MESH WAS INCORPORATED WITH OMENTUM. AS REPORTED, THE VENTRALEX ST MESH WAS EXPLANTED DURING THIS PROCEDURE. 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 ST HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. A PIECE OF VENTRALEX ST WAS PLACED IN THE ABDOMEN AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH PAIN, DRAINAGE FROM SITE, RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH. PER OPERATIVE NOTES, ¿THERE WAS INFLAMMATORY REACTION AROUND THE UMBILICUS AT LEVEL OF THE REPAIR AND THE MESH WAS INCORPORATED WITH OMENTUM. THE SUTURES WERE REMOVED, THE MESH WAS DISSECTED AWAY FROM THE ABDOMINAL WALL, INTRAABDOMINALLY IT WAS ADHERED TO THE OMENTUM AND THIS WAS ALSO TAKEN DOWN. THE SCAR TISSUE BENEATH THE UMBILICUS WAS TAKEN DOWN.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD HERNIA RECURRENCE, ADHESIONS, PAIN, INFLAMMATORY REACTION AROUND THE UMBILICUS AND MESH REMOVAL.

    Additional Manufacturer Narrative · 1

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. HERNIA RECURRENCE AND INFLAMMATION ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR 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

    IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. AS REPORTED, A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950007 LOT NUMBER HUZC0641 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT HERNIA DEFECT DUE TO AN INFLAMMATORY REACTION TO THE VENTRALEX ST MESH AND THE MESH WAS INCORPORATED WITH OMENTUM. AS REPORTED, THE VENTRALEX ST MESH WAS EXPLANTED DURING THIS PROCEDURE. 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 ST HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109276 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZC0641

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Disability| R