BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7260579 · Received February 9, 2018

    Report

    Report Number
    1213643-2018-00242
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    February 16, 2017
    Report Date
    July 5, 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 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 REMOVE THE VENTRALEX AS THE MESH HAD BECOME INFECTED AT THE ANTERIOR ABDOMINAL WALL". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORD REVIEW, ABOUT 4 YEARS 4 MONTHS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH INFECTION, GRANULATION AND INFLAMMATION THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS INFLAMMATION AS A POSSIBLE COMPLICATION. UPDATED FIELDS: A2, A4, B4, B5, B7, E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELD: H4 (MANUFACTURING DATE). 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

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH MESH, REFERENCE NUMBER (B)(4), LOT NUMBER HUVI0020WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE VENTRALEX AS THE MESH HAD BECOME INFECTED AT THE ANTERIOR ABDOMINAL WALL. AS ALLEGED, THE PATIENT WAS SEVERELY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED FREE CIRCUMFERENTIALLY AND REDUCED. THE VENTRALEX MESH WAS PLACED INSIDE THE ABDOMEN, SUTURED CIRCUMFERENTIALLY IN A WAY THE SMOOTH SIDE FACING INWARD.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INFECTION THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE OLD MESH WAS DISSECTED AND GRANULATION TISSUES WERE REMOVED ALONG WITH THE MESH. CHRONIC INFLAMMATION FOUND IN THE MIDDLE FASCIA. A TISSUE GRAFT WAS PLACED INSIDE AND THE MIDLINE WAS CLOSED WITH SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD INFECTION, INFLAMMATION, ABSCESS, PAIN, NEED FOR CORRECTIVE AND ADDITIONAL SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE 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 REMOVE THE VENTRALEX AS THE MESH HAD BECOME INFECTED AT THE ANTERIOR ABDOMINAL WALL". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH MESH, REFERENCE NUMBER 0010301, LOT NUMBER HUVI0020WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE VENTRALEX AS THE MESH HAD BECOME INFECTED AT THE ANTERIOR ABDOMINAL WALL. AS ALLEGED, THE PATIENT WAS SEVERELY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103951 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVI0020 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Disability| R