PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA POST IMPLANT OF PHASIX FLAT MESH. THE SEROMA RESOLVED WITHOUT INTERVENTION. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE SEROMA AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EXTENT TO WHICH THE PHASIX FLAT MESH IMPLANT USED TO TREAT THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S POSTOPERATIVE SEROMA CANNOT BE DETERMINED. HENCE, NO CONCLUSIONS CAN BE MADE. SEROMA FORMATION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT OF (B)(4) 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)(6): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY, COLECTOMY, EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (39 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 30 CM IN LENGTH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED A SMALL SEROMA ON INCISION SITE, NO TREATMENT OR TEST DONE. THE SEROMA WAS RESOLVED ON (B)(6) 2026. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLE RELATED TO THE STUDY DEVICE AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY AND RECOVERED AND 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).