BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 7302421 · Received February 28, 2018

    Report

    Report Number
    1213643-2018-00407
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    August 20, 2013
    Report Date
    October 28, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031199
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X WHICH FAILED, AND TO RESECTION THE SMALL BOWEL. 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. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE DATE OF EXPLANT AND 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 7 YEARS 6 MONTHS POST IMPLANT OF COMPOSIX E/X MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS AND ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AND ADHESIONS 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, B7, D4 (UDI NO), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELDS: D.6B (DATE OF EXPLANT), 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: ON (B)(6) 2006: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH, REFERENCE NUMBER 0123680, LOT NUMBER 43HOD399 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X WHICH FAILED, AND TO RESECTION THE SMALL BOWEL. IT IS ALLEGED THAT THE PATIENT SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X HERNIA PATCH. 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 MESH. PER OPERATIVE NOTES, ¿ALL THE ADHESIONS FROM THE HERNIA WERE CLEARED. A COMPOSIX E/X MESH WAS TACKED IN THE OVERLYING FASCIA. ¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH DIVERTICULITIS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL REMOVAL OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, ¿SIGNIFICANT SMALL BOWEL AND OMENTAL ADHESIONS TO THE RIGHT LOWER QUADRANT WAS NOTED. THERE WAS A LOOP OF INTESTINE WITH PIECE OF MESH THAT HAD GROWN INTO IT AND THIS COMPOSIX E/X MESH WAS PARTIALLY EXCISED.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, ¿CECUM AND MULTIPLE LOOPS OF SMALL BOWEL ADHERENT TO THE MESH WAS IDENTIFIED IN THE RIGHT LOWER QUADRANT. THE MESH WAS EXTREMELY BALLED UP AND THERE WERE MULTIPLE CLIPS WITH ADHERENT BOWEL. THE MESH WAS REMOVED AND MULTIPLE ADHESIONS WERE DISSECTED OFF.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, BOWEL OBSTRUCTION, BOWEL PERFORATION, MESH MIGRATION, NERVE DAMAGE, PAIN, HERNIA RECURRENCE, SEROMA AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT HAD DIVERTICULITIS AND DAILY MUSCLE CRAMPS.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X WHICH FAILED, AND TO RESECTION THE SMALL BOWEL. 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. 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 AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH, REFERENCE NUMBER 0123680, LOT NUMBER 43HOD399 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X WHICH FAILED, AND TO RESECTION THE SMALL BOWEL. IT IS ALLEGED THAT THE PATIENT SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146100 COMPOSIX MESH E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HOD399 00801741031199

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Disability| R