BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 7237210 · Received February 2, 2018

    Report

    Report Number
    1213643-2018-00181
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    February 2, 2009
    Report Date
    July 10, 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 #1 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY TO "INCISE THE HERNIA MESH BECAUSE OF A BOWEL OBSTRUCTION" HOWEVER MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. BASED ON THE DESCRIPTION IT IS UNCLEAR WHICH MESH WAS "INCISED" DURING TREATMENT OF BOWEL OBSTRUCTION. 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: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE DATE OF EVENT AND MANUFACTURING DATE. UPON REVIEW OF MEDICAL RECORDS, IT WAS CONFIRMED THERE WAS NO ADVERSE EVENT OR MEDICAL/SURGICAL INTERVENTION ASSOCIATED TO THE COMPOSIX MESH IMPLANTED TO TREAT THE PATIENT'S LARGE EPIGASTRIC VENTRAL INCISIONAL HERNIA. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. CORRECTED FIELD: B3 (DATE OF EVENT), H4 (MANUFACTURING DATE) THIS SUPPLEMENTAL EMDR REPRESENTS THE MESH - COMPOSIX (DEVICE #1). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE MESH - COMPOSIX (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) 2002: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113360 AND LOT NUMBER 43DLD067 (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2002: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT VENTRAL INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113360 AND LOT NUMBER 43AMD097 (DEVICE #2) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO "INCISE THE HERNIA MESH BECAUSE OF A BOWEL OBSTRUCTION." IT IS ALLEGED BY THE ATTORNEY, THE COMPOSIX 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. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH LARGE EPIGASTRIC VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. THERE WERE EXTENSIVE ADHESIONS THAT HAD TO BE RELEASED. A COMPOSIX MESH (DEVICE #1) WAS TRIMMED, PLACED INTRAPERITONEALLY AND ANCHORED TO THE ANTERIOR ABDOMINAL WALL WITH SUTURES.¿ ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL INCISIONAL HERNIA FROM UMBILICUS TO ABOVE THE PUBIC SYMPHYSIS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS FREED. THE EDGES OF THE VENTRAL DEFECT IDENTIFIED, AND SCAR DEBRIDED. A COMPOSIX MESH (DEVICE #2) PLACED TO THE ANTERIOR MIDLINE TO BUTTRESS THE HERNIA DEFECT AND ANCHORED WITH SUTURES.¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF COMPOSIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE MESH HAD DENSE ADHESIONS OF THE SMALL BOWEL. THE SMALL BOWEL WAS RESECTED FROM THE SURROUNDING MESH AND THE MADE ENTEROTOMY REPAIRED USING SUTURES. THERE WERE EXTENSIVE ADHESIONS BOTH PROXIMAL AND DISTAL WHICH CONTRIBUTED TO THE OBSTRUCTIVE PROCESS. THE MESH WAS THEN EXCISED DUE TO POOR PLACEMENT AND CONTAMINATION.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, PAIN, HERNIA RECURRENCE, INFECTION, MESH INCISION 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 #1 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY TO "INCISE THE HERNIA MESH BECAUSE OF A BOWEL OBSTRUCTION" HOWEVER MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. BASED ON THE DESCRIPTION IT IS UNCLEAR WHICH MESH WAS "INCISED" DURING TREATMENT OF BOWEL OBSTRUCTION. 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. THIS EMDR REPRESENTS THE BARD DEVICE IMPLANTED ON (B)(6) 2002 (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE IMPLANTED ON (B)(6) 2002 (DEVICE #2) . 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2002: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113360 AND LOT NUMBER 43DLD067 (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2002: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT VENTRAL INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113360 AND LOT NUMBER 43AMD097 (DEVICE #2) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO "INCISE THE HERNIA MESH BECAUSE OF A BOWEL OBSTRUCTION." IT IS ALLEGED BY THE ATTORNEY, THE COMPOSIX 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. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80375 MESH - COMPOSIX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DLD067

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Disability| R