BASED ON THE INFORMATION PROVIDED AND THE PATIENT'S COMPLEX MEDICAL/SURGICAL HISTORY, NO CONCLUSION CAN BE MADE AT THIS TIME. INFECTION IS A KNOWN INHERENT RISK OF ANY SURGICAL PROCEDURE, THE WARNING SECTION OF THE IFU STATES, "THIS DEVICE IS NOT INDICATED FOR THE TREATMENT OF INFECTION. IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY." A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR 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. DEVICE REMAINS IMPLANTED.
D
Patient 1
IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST SURGICAL SITE INFECTION. AS REPORTED THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT ON (B)(6) 2016. DURING A FOLLOW UP VISIT, THE PATIENT WAS NOTED TO HAVE A PURULENT AND SEROSANGUINOUS COLLECTION. A SURGICAL DRAIN WAS PLACED ON (B)(6) 2016 IN THE LEFT UPPER QUADRANT IN THE INTRAPERITONEAL SPACE. THIS DRAIN WAS SUBSEQUENTLY REMOVED ON (B)(6) 2016. A SECOND DRAIN WAS PLACED ON (B)(6) 2016 IN THE RIGHT UPPER QUADRANT, RETRO-RECTUS SPACE. THIS DRAIN WAS REMOVED ON (B)(6) 2016. PATIENT WAS DIAGNOSED WITH A SURGICAL SITE INFECTION WITH PURULENT DRAINAGE FROM THE DEEP INCISION. CULTURES WERE OBTAINED WITH BACTERIA IDENTIFIED AS ESCHERICHIA COLI, KLEBSIELLA, ENTEROCOCCUS AND CANDIDA. THIS ADVERSE EVENT WAS CONSIDERED SEVERE AND REQUIRED PROLONGED HOSPITALIZATION AND ADDITIONAL MEDICAL/SURGICAL TREATMENT. THE PATIENT IS NOTED TO HAVE RECOVERED WITH THE INFECTION RESOLVED.