BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 7315902 · Received March 6, 2018

    Report

    Report Number
    1213643-2018-00459
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    March 26, 2008
    Report Date
    October 25, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016530
    PMA / PMN Number
    PREAMENDMENT
    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 IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. NO SPECIFIC DEVICE FAILURE HAS BEEN REPORTED NOR HAVE MEDICAL RECORDS BEEN PROVIDED BY THE PATIENTS ATTORNEY. 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 10 MONTHS POST IMPLANT OF BARD FLAT MESH, PATIENT WAS DIAGNOSED HERNIA RECURRENCE, ADHESIONS, INFLAMMATION, FIBROSIS AND PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESION AND INFLAMMATION AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, B4, B5, B6, B7, D4 (UDI NO), D.6B (DATE OF EXPLANT), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELD: H4 (MANUFACTURING DATE) THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD FLAT MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #1). 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)2007 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. AS REPORTED, A MARLEX MESH, REFERENCE NUMBER 0112680 AND LOT NUMBER 43ARD262 (DEVICE #1) AND 43JQD263 (DEVICE #2), WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE VENTRAL/INCISIONAL HERNIA." AS REPORTED BY THE ATTORNEY, THE MARLEX USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH TWO LARGE VENTRAL HERNIA ONE IN THE MIDDLE AND RIGHT LOWER QUADRANT THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE SMALL AND LARGE INTESTINE PROTRUDED THROUGH THE HERNIA WERE ABLE TO PUSH IT BACK INTO THE ABDOMINAL CAVITY AFTER AN EXTENSIVE ADHESIOLYSIS. AFTER THE FASCIAL DEFECT WAS APPROXIMATED, MARLEX MESH WAS PLACE TO REINFORCE THE FASCIA AND 2 ON-Q CATHETERS WERE PLACED ABOVE THE MARLEX MESH AND SUTURED.¿ ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH COMPLEX VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF BARD FLAT MESH (DEVICE #1 & #2) AND IMPLANT OF PERMACOL MESH. PER OPERATIVE NOTES, ¿THERE WERE MULTIPLE COMPLEX HERNIA DEFECTS. COLOSTOMY WAS PERFORMED IN THE RIGHT LATERAL ABDOMEN AND A PIECE OF SYNTHETIC MESH WAS SEWED INTO THE DEFECT WITH SUTURES. A LARGE PIECE OF MESH IN THE RIGHT LOWER QUADRANT WAS RESECTED.¿ ATTORNEY ALLEGED THAT THE PATIENT HAD ADHESIONS, INFECTION, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

    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 IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. NO SPECIFIC DEVICE FAILURE HAS BEEN REPORTED NOR HAVE MEDICAL RECORDS BEEN PROVIDED BY THE PATIENTS ATTORNEY. THIS EMDR WILL REFLECT THE INFORMATION FOR DEVICE #2, A SEPARATE EMDR SHALL BE FILED FOR DEVICE #1. 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 PATIENT'S ATTORNEY THAT ON (B)(6) 2007 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. AS REPORTED, A MARLEX MESH, REFERENCE NUMBER 0112680 AND LOT NUMBER 43ARD262 (DEVICE #1) AND 43JQD263 (DEVICE #2), WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE VENTRAL/INCISIONAL HERNIA." AS REPORTED BY THE ATTORNEY, THE MARLEX USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161789 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JQD263 00801741016530

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Disability| R