BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 7326879 · Received March 9, 2018

    Report

    Report Number
    1213643-2018-00519
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    January 15, 2014
    Report Date
    October 23, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016493
    PMA / PMN Number
    PREAMENDMENT
    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 FOR THE EXCISION OF THE FISTULA TRACT AND RECREATION OF THE UMBILICUS". THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. FISTULA FORMATION 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 8 MONTHS POST IMPLANT OF BARD FLAT MESH, PATIENT WAS DIAGNOSED WITH FISTULA AND PAIN THEREBY UNDERWENT REPAIR. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, B4, B5, B7, D4 (UDI NO), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELDS: 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) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL FLAT MESH (MARLEX), REFERENCE NUMBER (B)(4), LOT NUMBER HUUG1390 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR EXCISION OF THE FISTULA TRACT AND RECREATION OF THE UMBILICUS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE BARD FLAT MESH (MARLEX). ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH. PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS FOUND AND A MARLEX MESH WAS PLACED IN AN UNDERLAY FASHION AND SUTURED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH FISTULA THEREBY UNDERWENT OPEN REPAIR WITH THE EXCISION OF FISTULA TRACT AND RECREATION OF UMBILICUS. PER OPERATIVE NOTES, ¿A SILK SUTURE THAT MOST LIKELY THE CAUSE OF THE FISTULA. IT WAS EXCISED AND THE SURROUNDING SOFT TISSUES WERE EXTENSIVELY INFLAMED AND REQUIRED EXCISION. THE AREA WAS FULLY DEBRIDED AND THIS CREATED A WOUND THAT WAS FULLY IRRIGATED AND PROCEEDED WITH RECREATION OF THE UMBILICUS." ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, FISTULAE, INFECTION, RECREATION OF UMBILICUS 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 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 FOR THE EXCISION OF THE FISTULA TRACT AND RECREATION OF THE UMBILICUS". THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. FISTULA FORMATION IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. 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) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL FLAT MESH (MARLEX), REFERENCE NUMBER 0112640, LOT NUMBER HUUG1390 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR EXCISION OF THE FISTULA TRACT AND RECREATION OF THE UMBILICUS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE BARD FLAT MESH (MARLEX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171246 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUG1390 00801741016493

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Disability| R