BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 7213275 · Received January 23, 2018

    Report

    Report Number
    1213643-2018-00102
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    July 28, 2011
    Report Date
    April 1, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    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 REPAIR THE HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. ADDITIONALLY, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH, WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, 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. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT FEW MONTHS POST IMPLANT OF COMPOSIX MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, BACTERIAL INFECTION, ADHESION, ABSCESS AND SEROMA THEREBY UNDERWENT REPAIRS WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS SEROMA AND ADHESION AS A POSSIBLE COMPLICATION. IN REGARD TO THE INFECTION, THE WARNING SECTION OF THE IFU 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." UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D.6B (DATE OF EXPLANT), E3, G1, G3, G6, H2, H6, H10 THIS SUPPLEMENTAL EMDR IS SUBMITTED TO REPRESENTS MESH - COMPOSIX (DEVICE #1). ADDITIONAL EMDRS WERE SUBMITTED TO REPRESENT THE VENTRIO MESH (DEVICE #2) AND VENTRIO ST (DEVICE #3). 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 INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113680 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2011: THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT." AS REPORTED BY THE ATTORNEY, THE COMPOSIX 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. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND MULTIPLE MIDLINE VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿AT THE DISTAL LOCATION BELOW THE UMBILICUS THERE WERE THREE SEPARATE DEFECTS AS WELL AS AN UMBILICAL DEFECT INFERIORLY. THERE WERE EXTENDING XIPHOID MULTIPLE SMALL DEFECTS ALMOST UP TO XIPHOID PROCESS. COMPOSIX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE FASCIA WAS GENTLY OPENED JUST IN FRONT OF THE MESH. THE COMPOSIX MESH (DEVICE #1) APPEARS TO BE ENTIRELY INTACT AND ATTACHED TO ITS LATERAL MARGINS SUPERIORLY AND INFERIORLY. THE RESULTANT DEFECT WAS FROM THE FRACTURED SUTURE IN THE MID-PORTION OF PREVIOUS REPAIR AND THIS WAS REMOVED. TWO PROLENE SUTURES USED TO REAPPROXIMATE THE FASCIA OVER THE MESH.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MINIMAL SEROUS FLUID ACCUMULATION ALONG THE ANTERIOR ABDOMINAL MIDLINE WHICH COULD NOT BE ASPIRATED DURING ULTRASOUND GUIDED ASPIRATION PROCEDURE. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WOUND AND ABSCESS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE COMPOSIX MESH (DEVICE #1) IS EXPOSED AND COMPLETELY REMOVED FROM ITS PREPERITONEAL ATTACHMENT. ADHESIONS FROM THE ANTERIOR ABDOMINAL WALL AND THE OMENTUM WERE TAKEN DOWN ALONG WITH MESH.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR AND EXCISION OF SKIN LESION OF LEFT FOREARM. PER OPERATIVE NOTES, ¿RECURRENT DEFECTS WERE IDENTIFIED IN THE MIDLINE. MESH (UNKNOWN) PREVIOUSLY PLACED LAPAROSCOPICALLY WAS NOTED TO BE IN GOOD ATTACHMENT AND MIDLINE FASCIA WAS APPROXIMATED WITH SUTURES.¿ (NOTE, NO PRODUCT IDENTIFIERS WERE PROVIDED FOR THE UNKNOWN LAPAROSCOPICALLY PLACED MESH) (B)(6) 2013 - PATIENT ADMITTED FOR RECURRENT INCISIONAL HERNIA REPAIR. (B)(6) 2013 - PATIENT UNDERWENT OPEN RECURRENT INCISIONAL HERNIA REPAIR. PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED (UNKNOWN) MESH LAPAROSCOPICALLY APPEARS TO BE INTACT ALONG THE ANTERIOR ABDOMINAL WALL. THE MIDLINE DEFECT WAS APPROXIMATED WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿MESH (UNKNOWN) WAS IDENTIFIED WHICH WAS GENTLY DISASSEMBLED OR DISCONNECTED FROM THE ANTERIOR ABDOMINAL WALL, BOTH LEFT AND RIGHT SUPERIORLY AND INFERIORLY UNTIL WE COULD COVER THE SPACE BEYOND WHERE THE MESH HAD BEEN DISCONNECTED. A PIECE OF VENTRIO MESH (DEVICE #2) WAS SECURED IN POSITION WITH THE TACKER BOTH SUPERIORLY AND INFERIORLY ON THE RIGHT AND LEFT LATERAL SIDES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #3). PER OPERATIVE NOTES, ¿FREED THE ABDOMINAL MUSCULATURE CIRCUMFERENTIALLY AROUND THE HERNIA DEFECT. THIS EXTENDS INFERIORLY TO THE OLD MESH (DEVICE #2) WHICH APPEARS TO BE INTACT UP TOWARD THE XIPHOID PROCESS. HERNIA REPAIR IS ACCOMPLISHED BY PLACING VENTRIO ST MESH (DEVICE #3) IN THE PREPERITONEAL SPACE AND SUTURED.¿ (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, ADHESIONS THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿THERE WERE DENSE ADHESIONS OF THE OMENTUM AND SMALL LOOPS OF BOWEL TO THE ANTERIOR ABDOMINAL WALL, WHERE THERE WAS A PIECE OF MESH (DEVICE #2 & #3) WAS PLACED FROM PRIOR HERNIA REPAIR. ADHESIONS OF THE OMENTUM, BOWEL TO THE ANTERIOR ABDOMINAL WALL, SMALL BOWEL LOOP WERE TAKEN DOWN. THERE WAS NO EVIDENCE OF RECURRENT HERNIA.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, INFECTION, PAIN, HERNIA RECURRENCE, CONSTIPATION 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 TO REPAIR THE HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. ADDITIONALLY, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH, WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, 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. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. 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 INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113680 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2011: THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT." AS REPORTED BY THE ATTORNEY, THE COMPOSIX 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. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56671 MESH - COMPOSIX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Disability| R