PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DIAGNOSED WITH SEROMA AND UNDERWENT DRAINAGE POST IMPLANT OF PHASIX MESH. THE REPORTED POST OPERATIVE SEROMA HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE 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. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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 THE CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT A LAPAROSCOPIC PRIMARY LAPAROTOMY, EXPLORATORY LAPAROTOMY, HYSTERECTOMY AND OOPHORECTOMY DURING WHICH A PHASIX FLAT MESH WAS PLACED. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT DEVELOPED A SEROMA AND UNDERWENT FLUID DRAINAGE AT THEIR PHYSICIAN¿S REQUEST, DURING WHICH A DRAIN WAS PLACED. THE PATIENT WAS NOT HOSPITALIZED AND WAS PRESENT FOR ONLY A COUPLE OF HOURS. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLE RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY AND ASSESSED AS RECOVERED/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).