PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED STAPHYLOCOCCUS EPIDERMIDIS BACTEREMIA POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. THIS PRODUCT IS SUPPLIED SINGLE USE STERILE. INFECTION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT OF 97 UNITS RELEASED FOR DISTRIBUTION. 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.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 UNDERWENT AN OPEN PRIMARY LAPAROTOMY PANCREATODUODENECTOMY SUBXIPHOID EPIGASTRIC UMBILICAL CHOLECYSTECTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH NON- ABSORBABLE MONOFILAMENT SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 44CM IN LENGTH. THE SUBJECT PATIENT HAD CEFOXITIN AND TAZOCILLIN ANTIBIOTICS USED PERI OPERATIVELY. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED STAPHYLOCOCCUS EPIDERMIDIS BACTEREMIA WAS DEVELOPED. PATIENT WAS ADMINISTRATED WITH LINEZOLIDE IV FROM (B)(6) 2025, THEN DAPTOMYCINE FROM (B)(6) 2025. THE BACTEREMIA RESOLVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE REPORTED ADVERSE EVENTS (STAPHYLOCOCCUS EPIDERMIDIS BACTEREMIA) HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSAL RELATIONSHIP TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).