PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH FLUID ACCUMULATION IN THE SOFT TISSUES BENEATH THE ABDOMINAL WALL (SEROMA) POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE SEROMA AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE 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 DVL-HE-018: THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2026. SUBJECT PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS (CEFOXITIN) PRESCRIBED PERI-OPERATIVELY. ON (B)(6) 2026 THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROTOMY PROCEDURE CYSTECTOMY OSTOMY CREATION/REVISION/REVERSAL DURING WHICH A PHASIX FLAT MESH WAS TRIMMED AND PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MULTIFILAMENT SUTURES IMPLANTED. PATIENT HAD ABDOMINAL PAIN AND UROSCAN WAS PERFORMED ON (B)(6) 2026 SHOWING A SMALL SUBCUTANEOUS MASS (SEROMA) ON THE RIGHT SIDE OF THE ABDOMEN MEASURING APPROXIMATELY 2CM. AS REPORTED, THE ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLE RELATED TO STUDY DEVICE AND CAUSAL TO THE PROCEDURE. THE SEVERITY HAS BEEN ASSESSED AS MODERATE AND HAS RECOVERED/RESOLVED. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).