PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, POST IMPLANT OF THE PHASIX MESH AS AN ONLAY, THE SUBJECT PATIENT HAD DEVELOPED AN ASYMPTOMATIC SEROMA OBSERVED ON CT SCAN. NO FURTHER TREATMENT WAS REQUIRED. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE ASYMPTOMATIC SEROMA AS CAUSALLY RELATED TO THE STUDY DEVICE AND 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 ASYMPTOMATIC 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. 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 HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025 THE SUBJECT PATIENT UNDERWENT OPEN PRIMARY LAPAROTOMY PROCEDURE FOR DOUBLE BILIARY AND DIGESTIVE BYPASS AND CHOLECYSTECTOMY DURING WHICH A PHASIX FLAT MESH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. THE MIDLINE FASCIA WAS SECURED USING 2-0 PDS SLOW ABSORBABLE MONOFILAMENT SUTURES AND A SURGICAL DRAIN PLACED. THE PATIENT WAS PRESCRIBED TAZOCILLIN PROPHYLACTICALLY AND DISCHARGED ON (B)(6) 2025. ON (B)(6) 2026, CT SCAN REVEALED AN ASYMPTOMATIC SEROMA MEASURING 12 CM AT THE MIDLINE LAPAROTOMY SITE, NO FURTHER TREATMENT WAS REQUIRED. AS REPORTED, THE ADVERSE EVENT (ASYMPTOMATIC SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS CAUSALLY RELATED TO BOTH STUDY DEVICE AND PROCEDURE AND CURRENTLY RECOVERING/RESOLVING. THE SEVERITY HAS BEEN ASSESSED AS MILD. 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).