PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN INCISIONAL HERNIA WITH PAIN POST IMPLANT OF THE PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME (INCISIONAL HERNIA) AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT 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.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY AND WHIPPLE PRIMARY LAPAROTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2024. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED INCISIONAL HERNIA WITH PAIN EXACERBATION AND ON (B)(6) 2025 PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT PARTIAL REMOVAL OF MESH AND REOPERATED WITH NEW MESH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THE REPORTED ADVERSE EVENTS (INCISIONAL HERNIA) HAVE BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERED/RESOLVED. 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).