BASED ON THE INFORMATION PROVIDED AND THE PATIENT'S COMPLEX MEDICAL 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. 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, WHO HAS A HIGHLY COMPLEX MEDICAL HISTORY, UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT ON (B)(6) 2016. PATIENT WAS EVALUATED AT A FOLLOW UP VISIT ON (B)(6) 2016 IN WHICH THE INFERIOR HALF OF THE INCISION WAS NOTED TO HAVE SURROUNDING INDURATION AND BLANCHING ERYTHEMA. THE PATIENT WAS DIAGNOSED TO HAVE AN ABSCESS (RECTORECTUS BUT ANTERIOR TO MESH) ON (B)(6) 2016. THIS AE HAS BEEN DEFINED AS SEVERE AND POSSIBLY RELATED TO THE DEVICE WITH PROLONGED HOSPITALIZATION AND ADDITIONAL MEDICAL/SURGICAL INTERVENTION. ONE DRAIN WAS PLACED IN THE RIGHT LOWER QUADRANT IN THE RETRO-RECTUS SPACE ON (B)(6) 2016. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FOR A DEEP WOUND SURGICAL SITE INFECTION. CULTURES WERE OBTAINED AND REVEALED BACTERIAL GROWTH OF (B)(6) AND ENTEROBACTER CLOACAE. NO MESH INFECTION WAS IDENTIFIED. THERE WAS NOTED TO HAVE BEEN A DEHISCENCE OF THE INCISIONAL WOUND. TREATMENT IS ONGOING AT THIS TIME.