PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, POST IMPLANT OF THE PHASIX MESH AS AN ONLAY, THE SUBJECT PATIENT HAD DEVELOPED A SEROMA. NO FURTHER TREATMENT WAS REQUIRED. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE SEROMA AS CAUSALLY RELATED TO BOTH STUDY DEVICE AND 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 SEROMA IS UNKNOWN. 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. 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) 2026 UNDERWENT AN OPEN LAPAROSCOPIC PRIMARY LAPAROSCOPIC LAPAROTOMY AND COLECTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (11 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 32 CM IN LENGTH. PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS (METRONIDAZOLE, CEFOXITIN), PRESCRIBED PERI-OPERATIVELY. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026 - THE SUBJECT PATIENT DEVELOPED A SEROMA, NO TREATMENT OR MEDICATION REQUIRED. THE SEROMA WAS RECOVERING AND RESOLVING. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, AND THE AE IS RECOVERING AND RESOLVING; THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).