PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED A PARARECTAL INCISIONAL HERNIA AT THE LEVEL OF THE FISTULA RESECTION TRACT POST IMPLANT OF PHASIX MESH PLACED AS AN ONLAY. AS REPORTED NO TREATMENT OR MEDICATION WAS REQUIRED. THE REPORTED PARARECTAL INCISIONAL HERNIA HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EXTENT TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S POSTOPERATIVE HERNIA CANNOT BE DETERMINED. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS OR TO PREVENT OCCURRENCES WHEN REINFORCING SURGICAL INCISIONS PROPHYLACTICALLY, THE MESH SHOULD BE SIZED WITH APPROPRIATE OVERLAP FOR THE SIZE AND LOCATION OF THE DEFECT OR SURGICAL INCISION, TAKING INTO CONSIDERATION ANY ADDITIONAL CLINICAL FACTORS APPLICABLE TO THE PATIENT. CAREFUL ATTENTION TO MESH FIXATION PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR GAP FORMATION BETWEEN THE MESH AND FASCIAL TISSUE." A REVIEW OF THE MANUFACTURING RECORDS SHOWS THE LOT WAS MANUFACTURED ACCORDING 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) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT AN OPEN RELAPAROTOMY, ILEOCOLIC ANASTOMOSIS RESECTION, NEW ILEOCOLIC ANASTOMOSIS AND EXCISION OF THE PARIETAL TRACT OF THE ENTEROCUTANEOUS FISTULA DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2.0 MONOCRYL ETHICON. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (31 CM LENGTH AND 6 CM WIDTH). THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 52 CM IN LENGTH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED A RIGHT PARARECTAL INCISIONAL HERNIA AT THE LEVEL OF THE FISTULA RESECTION TRACK, NO TREATMENT OR MEDICATION REQUIRED. THE REPORTED ADVERSE EVENT (RIGHT PARARECTAL INCISIONAL HERNIA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. THE SEVERITY HAS BEEN ASSESSED AS MODERATE AND RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).