BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 7302358 · Received February 28, 2018

    Report

    Report Number
    1213643-2018-00401
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 12, 2015
    Report Date
    October 18, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031182
    PMA / PMN Number
    K002684
    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 #2 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA AND THAT DURING THAT PROCEDURE "THE PREVIOUSLY IMPLANTED MESH WAS DISCOVERED AND REMOVED". THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE "DISCOVERED AND REMOVED" MESH REFERS TO DEVICE #1, DEVICE #2, OR BOTH. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 8 YEARS 5 MONTHS POST IMPLANT OF COMPOSIX E/X MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THIS SUPPLEMENTAL EMDR REPRESENTS COMPOSIX E/X MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR HAS BEEN SUBMITTED TO REPRESENT COMPOSIX E/X MESH (DEVICE #1). 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: (B)(6)2006: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX E/X MESH (DEVICE #1), REFERENCE NUMBER (B)(4) AND A BARD/DAVOL COMPOSIX E/X MESH (DEVICE #2), REFERENCE NUMBER (B)(4) WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. AS REPORTED, SUBSEQUENT TO HER IMPLANT SURGERY, THE PATIENT BEGAN TO SUFFER SYMPTOMS OF ABDOMINAL PAIN AND ABDOMINAL DISTENTION WHICH EVENTUALLY NECESSITATED ADDITIONAL SURGICAL INTERVENTION. (B)(6)2015: THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA. AS REPORTED, DURING THAT PROCEDURE, THE PREVIOUSLY IMPLANTED MESH WAS DISCOVERED AND REMOVED, AND A BARD/DAVOL PHASIX MESH (DEVICE #3), REFERENCE NUMBER (B)(4) WAS IMPLANTED. 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: (B)(6)2006 - PATIENT UNDERWENT HERNIA REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1 & #2). (NO IMPLANT OP NOTES WERE PROVIDED). (B)(6)2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE #3) AND EXPLANT OF COMPOSIX E/X MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE OLD MESH WAS ENCOUNTERED AND COMPLETELY REMOVED. AFTER ADEQUATE CLOSURE OF THE DEFECT, A PHASIX MESH (DEVICE #3) WAS PLACED AND SUTURED." ATTORNEY ALLEGED THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT PATIENT EXPERIENCED SUFFERING AND MENTAL ANGUISH THEREBY UNDERWENT ADDITIONAL INVASIVE SURGERIES FOR MESH REMOVAL WITH HOSPITALIZATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE #2 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA AND THAT DURING THAT PROCEDURE "THE PREVIOUSLY IMPLANTED MESH WAS DISCOVERED AND REMOVED". THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE "DISCOVERED AND REMOVED" MESH REFERS TO DEVICE #1, DEVICE #2, OR BOTH. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. THIS EMDR REPRESENTS THE BARD DEVICE #2 (COMPOSIX E/X MESH, REFERENCE NUMBER 0123460). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE #1 (COMPOSIX E/X MESH, REFERENCE NUMBER 0123680). NO ALLEGATIONS HAVE BEEN MADE REGARDING BARD DEVICE #3 (PHASIX MESH, REFERENCE NUMBER 1190300). 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.

    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 MESH (DEVICE #1), REFERENCE NUMBER 0123680 AND A BARD/DAVOL COMPOSIX E/X MESH (DEVICE #2), REFERENCE NUMBER 0123460 WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. AS REPORTED, SUBSEQUENT TO HER IMPLANT SURGERY, THE PATIENT BEGAN TO SUFFER SYMPTOMS OF ABDOMINAL PAIN AND ABDOMINAL DISTENTION WHICH EVENTUALLY NECESSITATED ADDITIONAL SURGICAL INTERVENTION. ON (B)(6) 2015: THE PATIENT UNDERWENT A REPAIR OF A RECURRENT INCISIONAL HERNIA. AS REPORTED, DURING THAT PROCEDURE, THE PREVIOUSLY IMPLANTED MESH WAS DISCOVERED AND REMOVED, AND A BARD/DAVOL PHASIX MESH (DEVICE #3), REFERENCE NUMBER 1190300 WAS IMPLANTED. 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
    145559 COMPOSIX MESH E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741031182

    Patients

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