BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 7197043 · Received January 16, 2018

    Report

    Report Number
    1213643-2018-00074
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    March 10, 2015
    Report Date
    February 21, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031212
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. 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. ADHESIONS ARE A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE MANUFACTURING DATE BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER THE MEDICAL RECORDS REVIEW, ABOUT SEVERAL YEARS POST IMPLANT OF COMPOSIX E/X MESH, THIS PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS AND ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE LIST HERNIA RECURRENCE AS A POSSIBLE COMPLICATION. 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. NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2007: THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR. A BARD/DAVOL COMPOSIX E/X REFERENCE NUMBER 0123810 LOT NUMBER 43DQD355 WAS IMPLANTED IN THIS PROCEDURE. (B)(6) 2015: THE PATIENT HAS THIS MESH REMOVED AFTER THEY FOUND THE MESH FAILED AND THERE WERE MULTIPLE ADHESIONS TO THE ABDOMINAL WALL. AS ALLEGED, THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, "LYSED OMENTAL AND SMALL BOWEL ADHESIONS. A LARGE AMOUNT OF INCARCERATED OMENTUM WITHIN HERNIA SAC WAS REDUCED, THEN THE REDUNDANT HERNIA SAC WAS INVERTED AND DETACHED FROM THE SUBCUTANEOUS TISSUE. A COMPOSIX E/X MESH WAS CUT IN A CONTOUR TO SNUGLY FIT AROUND THE AREA WITHIN PERITONEAL CAVITY AND TACKED WITH THE MESH SIDE FACING UPWARD TOWARD THE ANTERIOR ABDOMINAL WALL." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECTAL STRICTURE THEREBY UNDERWENT REPAIR. (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECTAL STRICTURE WITH FROZEN PELVIS AND MULTIPLE SMALL BOWEL LESIONS THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, "THERE WERE MULTIPLE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WHERE THE MESH WAS RE-PERITONEALIZING. THE MESH WAS DOUBLE-SIDED MESH WITH WHAT APPEARED TO BE A THIN CORTEX LINING ON THE INSIDE. THERE WERE STILL MULTIPLE ADHESIONS ADHERENT TO THIS AND WERE TAKEN DOWN. THE ENTIRE SMALL BOWEL WAS COVERED WITH SMALL LESIONS AND THESE WERE TAKEN DOWN." (B)(6) 2015 TO (B)(6) 2015 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN, PARTIAL SMALL BOWEL OBSTRUCTION WITH RIGHT INGUINAL HERNIA AND PARASTOMAL HERNIA. PATIENT HAD MULTIPLE ADMISSION FOR PARTIAL SMALL BOWEL OBSTRUCTION OVER LAST YEAR WHICH WAS TREATED NONOPERATIVELY. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, PARASTOMAL HERNIA AT COLOSTOMY SITE AND ILEAL CONDUIT SITE, LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, "ALONG THE MIDLINE NOTED ENTRY INTO THE PERITONEAL CAVITY BEFORE MESH WAS SEEN INDICATING A MESH FAILURE. LYSED ADHESIONS TO THE MESH AND THE HERNIA HAD RECURRED INFERIORLY IN SUPRAPUBIC POSITION, WHICH WAS THE LIKELY CAUSE OF PRIOR BOWEL OBSTRUCTIVE EPISODES. A LOOP OF SMALL BOWEL WAS INCARCERATED IN THIS HERNIA AND THERE WAS SMALL AMOUNT OF OMENTUM INCARCERATED INTO EACH OF THE PARASTOMAL HERNIA DEFECTS WHICH WAS FULLY REDUCED. COMPLETELY EXCISED THE MESH ALONG WITH ALL PERMANENT SUTURES AND TACKS. A LEFT INGUINAL HERNIA WAS REPAIRED USING A PIECE OF SYNTHETIC MESH AND OTHER SMALL PERITONEAL DEFECTS REPAIRED WITH ANOTHER PIECE OF SYNTHETIC MESH.¿ ATTORNEY ALLEGES THAT PATIENT UNDERWENT BOWEL OBSTRUCTION, ADHESIONS, MESH MIGRATION, HERNIA RECURRENCE, MESH FAILURE AND PAIN.

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. 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. ADHESIONS ARE A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2007: THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR. A BARD/DAVOL COMPOSIX E/X REFERENCE NUMBER 0123810, LOT NUMBER 43DQD355 WAS IMPLANTED IN THIS PROCEDURE. (B)(6) 2015: THE PATIENT HAS THIS MESH REMOVED AFTER THEY FOUND THE MESH FAILED AND THERE WERE MULTIPLE ADHESIONS TO THE ABDOMINAL WALL. AS ALLEGED, THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37653 COMPOSIX MESH E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DQD355 00801741031212

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Disability| R