BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 7316962 · Received March 6, 2018

    Report

    Report Number
    1213643-2018-00469
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    July 21, 2009
    Report Date
    November 12, 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

    THIS EMDR CORRECTS THE LOT EXPIRATION DATE FROM THE PREVIOUS EMDR. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    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 ADDITIONAL SURGERIES ON (B)(6)2009 AND (B)(6)2013 FOR REVISION USING "OLD MESH" AND RECURRENCE REPAIR. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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. ADDENDUM #1: H.11: THIS EMDR CORRECTS THE LOT EXPIRATION DATE (D.4), FROM THE PREVIOUS EMDR. ADDENDUM #2: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT DATE OF EVENT 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 1 YEAR 11 MONTHS POST IMPLANT OF COMPOSIX MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE THEREBY UNDERWENT REPAIR. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST HERNIA RECURRENCE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER (B)(4), LOT NUMBER 43JPD422 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009 AND (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERIES FOR REVISION USING "OLD MESH" AND RECURRENCE REPAIR. 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6)2007: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER (B)(4), LOT NUMBER 43JPD422 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6)2009 AND (B)(6)013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERIES FOR REVISION USING "OLD MESH" AND RECURRENCE REPAIR. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6)2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS IDENTIFIED. THE BOWEL AND THE OMENTUM AWAY FROM THE FASCIAL DEFECT WERE DISSECTED OUT. A COMPOSIX MESH (DEVICE #1) WAS PLACED AND SECURED BY USING SUTURE." (B)(6)2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. THE OMENTUM AND THE SMALL BOWEL WERE DETACHED. THE COMPOSIX MESH (DEVICE #1) WAS CRUMBLED UP AND THE SUTURE WAS DETACHED FROM THE LOWER PART OF THE FASCIA. THE DEFECT WAS IDENTIFIED AND SUTURED THE FASCIA AND THE OLD COMPOSIX MESH (DEVICE #1) TOGETHER." (B)(6)2013 - PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC INCLUDING SMALL BOWEL AS WELL AS TRANSVERSE COLON WAS DISSECTED OFF FROM THE ABDOMINAL WALL. A VENTRIO MESH (DEVICE #2) WAS PLACED AND SECURED BY USING SUTURES." (THERE WAS NO VISUALIZATION/MENTION OF COMPOSIX MESH (DEVICE #1)). ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, MESH MIGRATION, HERNIA RECURRENCE 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 ADDITIONAL SURGERIES ON (B)(6) 2009 AND (B)(6) 2013 FOR REVISION USING "OLD MESH" AND RECURRENCE REPAIR. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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. 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) 2007: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113680, LOT NUMBER 43JPD422 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009 AND (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERIES FOR REVISION USING "OLD MESH" AND RECURRENCE REPAIR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159301 MESH - COMPOSIX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JPD422

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability| R