PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT UNDERWENT AN OPEN RELAPAROTOMY WITH COLECTOMY AND LIVER RESECTION ON (B)(6) 2025. DURING THE PROCEDURE, THE PATIENT WAS IMPLANTED WITH PHASIX FLAT MESH. THE MESH WAS TRIMMED AND PLACED USING AN ONLAY TECHNIQUE AND FIXED WITH ABSORBABLE MULTIFILAMENT 2-0 PDS SUTURES SPACED 3 CM APART. THE MIDLINE FASCIA WAS COMPLETELY CLOSED USING SLOW-ABSORBING MONOFILAMENT 0 PDS SUTURES IN A RUNNING STITCH TECHNIQUE. AS REPORTED, ON (B)(6) 2025, THE PATIENT DEVELOPED ESCHERICHIA COLI INFECTION. A CT SCAN REVEALED LEFT BASE LUNG DISEASE, BUT NO SURGICAL SITE INFECTION WAS CONFIRMED. THE PATIENT WAS HOSPITALIZED FROM (B)(6) TO (B)(6) 2025 AND TREATED WITH TAZOCILLINE. AS REPORTED, THE ADVERSE EVENT (ESCHERICHIA COLI INFECTION) HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS POSSIBLY RELATED TO STUDY DEVICE, CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN E. COLI INFECTION POST IMPLANT OF A PHASIX MESH, HOWEVER, NO SURGICAL SITE INFECTION COULD BE CONFIRMED ON CT SCAN. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO STUDY DEVICE, CAUSALLY RELATED TO PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION REPORTED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE COURSE. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST INFECTION AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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.