BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 7212498 · Received January 23, 2018

    Report

    Report Number
    1213643-2018-00100
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    November 21, 2006
    Report Date
    March 21, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031212
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE IMPLANTED ON (B)(6)2006 (DEVICE #1) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE 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 THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 MONTHS POST IMPLANT OF COMPOSIX E/X MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS, SEROMA AND FIBROSIS THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESIONS AND SEROMA AS POSSIBLE COMPLICATIONS. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D1 (BRAND NAME), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELD: H4 (MANUFACTURING DATE) THIS SUPPLEMENTAL EMDR REPRESENTS COMPOSIX MESH E/X (DEVICE #1). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT BARD FLAT MESH (DEVICE #2). 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: ON (B)(6) 2006: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH, REFERENCE NUMBER 0123810 AND LOT NUMBER 43FQD145 (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2006: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. ON (B)(6) 2006: THE PATIENT "UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA WITH A MARLEX MESH, REFERENCE NUMBER 0112660 AND LOT NUMBER 43BOD020 (DEVICE #2) IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT." AS REPORTED BY THE ATTORNEY, THE COMPOSIX E/X AND MARLEX MESH 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 E./X AND MARLEX MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA WAS SEEN. A COMPOSIX E/X MESH (DEVICE #1) WAS THEN INSERTED INTO THE PERITONEAL CAVITY. THE MESH WAS THEN TACKED DOWN TO THE ANTERIOR ABDOMINAL WALL USING SUTURES AND PULLED DOWN TO THE ANTERIOR ABDOMINAL WALL WITH A TACKER.¿ ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND SEROMA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX E/X MESH (DEVICE #1) AND IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED DOWN THE FASCIA AND WAS OPENED. THE PREVIOUS MESH (DEVICE #1) WAS ALSO IN THE SAC AND WAS EXCISED ALONG WITH THE ADHERED OMENTUM. A BARD FLAT MESH (DEVICE #2) WAS PLACED ON EACH SIDE OF THE HERNIA AND TACKED IT DOWN WITH FASCIAL TACKER.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED VENTRAL HERNIA MESH WITH SMALL BOWEL FISTULA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF BARD FLAT MESH (DEVICE #2) AND SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THERE WERE LOOPS OF SMALL BOWEL THAT WERE FIRMLY ADHERED TO THE MESH. A SMALL AMOUNT OF SUCCUS WAS NOTED COMING OUT SUPERIOR TO THE MESH, THOUGHT TO BE A SMALL BOWEL FISTULA, LIKELY RESPONSIBLE FOR THE INFECTION. THIS WAS TAKEN OFF SHARPLY AND THE SMALL BOWEL WAS RESECTED. INFECTION OF THIS MESH WITH SUBSEQUENT DRAINAGE OF ABDOMINAL WALL ABSCESSES. THE MESH (DEVICE #2) WAS REMOVED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, BOWEL OBSTRUCTION, BOWEL REMOVAL, FISTULAE, INFECTION, PAIN, HERNIA RECURRENCE, SEROMA AND EMOTIONAL INJURIES. IT WAS ALSO ALLEGED THAT THE PATIENT HAD ADDITIONAL SURGERIES TO REPAIR THE HERNIA AND REMOVE THE MESH; PERMANENT AND SEVERE SCARRING AND DISFIGUREMENT.

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE IMPLANTED ON (B)(6) 2006 (DEVICE #1) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. THIS EMDR REPRESENTS THE BARD DEVICE IMPLANTED ON (B)(6) 2006 (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE IMPLANTED ON (B)(6) 2006 (DEVICE #2). 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) 2006: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH, REFERENCE NUMBER 0123810 AND LOT NUMBER 43FQD145 (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2006: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. ON (B)(6) 2006: THE PATIENT "UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA WITH A MARLEX MESH, REFERENCE NUMBER 0112660 AND LOT NUMBER 43BOD020 (DEVICE #2) IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT." AS REPORTED BY THE ATTORNEY, THE COMPOSIX E/X AND MARLEX MESH 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 E./X AND MARLEX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55719 COMPOSIX MESH E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD145 00801741031212

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Disability| R