PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 UNDERWENT AN OPEN RELAPAROTOMY WITH CONCOMITANT PROCEDURE OF TUBAL LIGATIONS DURING WHICH A PHASIX FLAT MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MONOFILAMENT SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. ON (B)(6) 2025 PATIENT WAS DIAGNOSED WITH A SUBCUTANEOUS SEROMA. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED SEROMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA FORMATION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY/USE OF THE DEVICE AND IT IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT 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.