BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 7080903 · Received December 4, 2017

    Report

    Report Number
    1213643-2017-00967
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    February 23, 2011
    Report Date
    August 29, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031168
    PMA / PMN Number
    K002684
    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 LIMITED 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. 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. THE WARNING SECTION OF THE IFU STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS, THE PROSTHESIS SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE MARGINS OF THE DEFECT." IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE 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 2 YEARS POST IMPLANT OF COMPOSIX E/X, PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, ADHESIONS, INFLAMMATION, ABSCESS AND HERNIA RECURRENCE THEREBY UNDERWENT MESH REMOVAL. PER THE OP-NOTES, ¿EDGES OF THE MESH HAD BEEN ROLLED¿. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE IDENTIFY ADHESIONS AND INFLAMMATION AS POSSIBLE COMPLICATIONS. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, E3, G1, G3, G6, H2, H6, H10, H11 CORRECTED FIELDS: D1 (BRAND NAME), 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

    IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. AS REPORTED, A BARD/DAVOL COMPOSIX E/X HERNIA PATCH MESH, REFERENCE NUMBER (B)(4), LOT NUMBER 43BPD262 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT SEVERAL YEARS LATER ON (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X, WHICH HAD FAILED, AND TO REPAIR THE RECURRENT INCISIONAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X. PER THE OPERATIVE NOTES, "THE HERNIA SAC WAS REDUCED. THE COMPOSIX E/X MESH WAS THEN PLACED AND SECURED. POLYSPORIN WAS THEN PLACED ON THE MESH." LATER A WEEK OF IMPLANT, PATIENT WAS HOSPITALIZED FOR 3 DAYS DUE TO ABDOMINAL PAIN, NAUSEA AND VOMITING. (B)(6) 2009 - PATIENT VISITED HOSPITAL DUE TO BOWEL OBSTRUCTION AND ABDOMINAL PAIN WITH CRAMPING. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REMOVAL OF PREVIOUS MESH. PER THE OPERATIVE NOTES, "ADHESIONS WERE TAKEN DOWN BETWEEN SMALL BOWEL AND THE EDGE OF THE MESH CIRCUMFERENTIALLY WHERE IT HAD ROLLED UNDER AND CREATED FAIR AMOUNT OF ADHESIONS. SCAR TISSUE WAS COMPLETELY TAKEN DOWN. WE HAD 5 ENTEROTOMIES. THE OLD MESH WAS COMPLETELY EXCISED." THEN A PIECE OF BIOLOGICAL MESH WAS PLACED. ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, HERNIA RECURRENCE, BOWEL OBSTRUCTIONS, PAIN, BOWEL REMOVAL AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE LIMITED 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. 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. THE WARNING SECTION OF THE IFU STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS, THE PROSTHESIS SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE MARGINS OF THE DEFECT." 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 PATIENTS ATTORNEY THAT ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. AS REPORTED, A BARD/DAVOL COMPOSIX E/X HERNIA PATCH MESH, REFERENCE NUMBER 0123113, LOT NUMBER 43BPD262 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT SEVERAL YEARS LATER ON (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X, WHICH HAD FAILED, AND TO REPAIR THE RECURRENT INCISIONAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860092 COMPOSIX MESH E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 0123113 43BPD262 00801741031168

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Disability| R